Job Description Purpose: The Senior Manager, Statistics provides statistical leadership to support the research and development organizations for drug discovery, target identification/verification, non-clinical and clinical biomarker exploration to characterize subgroups of patients or markers of disease progression and treatment response for precision medicine. The senior manager works independently in partnership with discovery researchers, translational scientists and clinicians in the design, collection, analysis and reporting of multi-dimensional biomarker data from Discovery to late stage clinical development to enable objective decision-making for each drug development program. Description: Provide statistical leadership in partnership with translational biomarker scientists and clinicians in the design, analysis and reporting of biomarker and assay studies in association with clinical trials, including pharmacodynamic/safety biomarker analyses, prognostic/predictive biomarker identification and development, bioassay and companion diagnostic test development, patient subgroup identification based on biomarkers and clinical variables. Support biomarker related responses during regulatory interactions and biomarker related product life-cycle management strategy planning and implementation Drive for scientific excellence in designing, analyzing and reporting of biomarker-based clinical trials or other scientific research studies. Independently developing biomarker section of clinical trial protocols or biomarker analysis plans. Work independently to implement sound statistical methodology in scientific investigations. Providing statistical leadership in partnership with scientists in discovery and translational science units in the design, analysis and reporting of in vitro, in vivo pharmacology studies, and human clinical trials. Identify markers and signatures from internal/external omics/imaging and other biomarker data for target identification, mechanism of action, resistant mechanism, disease progression, patient selection and stratification for precision medicine. Full accountability for data collection/integrity, and statistical analyses as per the biomarker analysis plan. Identifying and anticipating issues arising in the study design; conducting and proposing scientifically sound approaches. Evaluating appropriateness of available software for planned analyses and assessing needs for potential development of novel statistical methodology. Improving data presentation and inference with additional statistical and business insights. Collaborating in publication of scientific research. Ensuring that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided. Clearly explaining statistical concepts, enabling non-statisticians and biomarker collaborators to use existing tools and interpret results better. Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
03/30/2024
Full time
Job Description Purpose: The Senior Manager, Statistics provides statistical leadership to support the research and development organizations for drug discovery, target identification/verification, non-clinical and clinical biomarker exploration to characterize subgroups of patients or markers of disease progression and treatment response for precision medicine. The senior manager works independently in partnership with discovery researchers, translational scientists and clinicians in the design, collection, analysis and reporting of multi-dimensional biomarker data from Discovery to late stage clinical development to enable objective decision-making for each drug development program. Description: Provide statistical leadership in partnership with translational biomarker scientists and clinicians in the design, analysis and reporting of biomarker and assay studies in association with clinical trials, including pharmacodynamic/safety biomarker analyses, prognostic/predictive biomarker identification and development, bioassay and companion diagnostic test development, patient subgroup identification based on biomarkers and clinical variables. Support biomarker related responses during regulatory interactions and biomarker related product life-cycle management strategy planning and implementation Drive for scientific excellence in designing, analyzing and reporting of biomarker-based clinical trials or other scientific research studies. Independently developing biomarker section of clinical trial protocols or biomarker analysis plans. Work independently to implement sound statistical methodology in scientific investigations. Providing statistical leadership in partnership with scientists in discovery and translational science units in the design, analysis and reporting of in vitro, in vivo pharmacology studies, and human clinical trials. Identify markers and signatures from internal/external omics/imaging and other biomarker data for target identification, mechanism of action, resistant mechanism, disease progression, patient selection and stratification for precision medicine. Full accountability for data collection/integrity, and statistical analyses as per the biomarker analysis plan. Identifying and anticipating issues arising in the study design; conducting and proposing scientifically sound approaches. Evaluating appropriateness of available software for planned analyses and assessing needs for potential development of novel statistical methodology. Improving data presentation and inference with additional statistical and business insights. Collaborating in publication of scientific research. Ensuring that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided. Clearly explaining statistical concepts, enabling non-statisticians and biomarker collaborators to use existing tools and interpret results better. Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Job Description Purpose: The Senior Manager, Statistics provides statistical leadership to support the research and development organization for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients. description: Responsibilities: Protocols: Explore and select study designs aligned with Project Team strategy and goals. Provide sample-size, develop randomization specifications, and independently write statistical analysis plans to address study objectives. Ensure alignment of protocol with project and functional standards. Conduct quality review of protocol. Implement randomization schedules as planned with Interactive Response Technology vendor, Global Drug Supply Management, and other partners. Database Activities: Ensure data collection instruments are adequate and data collection is free of bias. Ensure database design satisfies statistical analysis requirements. Contribute to data monitoring plans. Develop and implement project-specific data standards. Identify and report data issues or violation of study assumptions. Guide programmers and data managers in preparing for database lock. Ensure accuracy of data released for statistical analysis. Statistical Analyses: Independently evaluate alternative complex or novel statistical approaches, make recommendations, approve, and implement. Influence non-statisticians to accept approach. Develop analysis plans ensuring statistical methods are appropriate with detail for programming. Ensure internal consistency of analysis plans. Perform statistical analyses per the SAP. Determine the need for development of novel statistical methodology. Reports and Publications: With project team, develop strategy for data presentation and inference. Independently write statistical methods and other sections of protocols, publications, etc., ensuring document templates followed. Identify and implement corrections to flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses conducted as planned with accuracy and internal consistency of writing including tables, listings and figures. Consultation: Work collaboratively with multi-function teams per agreed timelines. Timely inform management on important scientific/statistical issues that may arise. Provide responses to questions from clients and independently pursue analyses suggested by data. Effectively and persuasively present statistical concepts, evidence, assessment of risks and impacts. Demonstrate an understanding of drug development principles. External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with Academic and Contract Research Organizations. Communicate with statisticians outside PCYC concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department. Project Team Involvement: Represent the department on project team(s) to provide functional area input to compound/drug development. Serve as a liaison between the project team and the department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional area. Training and Mentoring: Maintain technical skills and increase knowledge of new statistical methods and areas of application through scientific literature and professional meeting attendance. Present own research or review of literature at meetings. Participate in departmental activities including recruiting, training/mentoring, research efforts, and cross-functional collaborations, as needed. Regulatory Activities: Participate with department management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies. Compliance: Compliant with applicable corporate and divisional policies, procedures, and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the Statistics function. Responsibly maintain department standards, GxP compliance, and best operating practices. Complete all assigned training on time.
03/29/2024
Full time
Job Description Purpose: The Senior Manager, Statistics provides statistical leadership to support the research and development organization for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients. description: Responsibilities: Protocols: Explore and select study designs aligned with Project Team strategy and goals. Provide sample-size, develop randomization specifications, and independently write statistical analysis plans to address study objectives. Ensure alignment of protocol with project and functional standards. Conduct quality review of protocol. Implement randomization schedules as planned with Interactive Response Technology vendor, Global Drug Supply Management, and other partners. Database Activities: Ensure data collection instruments are adequate and data collection is free of bias. Ensure database design satisfies statistical analysis requirements. Contribute to data monitoring plans. Develop and implement project-specific data standards. Identify and report data issues or violation of study assumptions. Guide programmers and data managers in preparing for database lock. Ensure accuracy of data released for statistical analysis. Statistical Analyses: Independently evaluate alternative complex or novel statistical approaches, make recommendations, approve, and implement. Influence non-statisticians to accept approach. Develop analysis plans ensuring statistical methods are appropriate with detail for programming. Ensure internal consistency of analysis plans. Perform statistical analyses per the SAP. Determine the need for development of novel statistical methodology. Reports and Publications: With project team, develop strategy for data presentation and inference. Independently write statistical methods and other sections of protocols, publications, etc., ensuring document templates followed. Identify and implement corrections to flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses conducted as planned with accuracy and internal consistency of writing including tables, listings and figures. Consultation: Work collaboratively with multi-function teams per agreed timelines. Timely inform management on important scientific/statistical issues that may arise. Provide responses to questions from clients and independently pursue analyses suggested by data. Effectively and persuasively present statistical concepts, evidence, assessment of risks and impacts. Demonstrate an understanding of drug development principles. External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with Academic and Contract Research Organizations. Communicate with statisticians outside PCYC concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department. Project Team Involvement: Represent the department on project team(s) to provide functional area input to compound/drug development. Serve as a liaison between the project team and the department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional area. Training and Mentoring: Maintain technical skills and increase knowledge of new statistical methods and areas of application through scientific literature and professional meeting attendance. Present own research or review of literature at meetings. Participate in departmental activities including recruiting, training/mentoring, research efforts, and cross-functional collaborations, as needed. Regulatory Activities: Participate with department management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies. Compliance: Compliant with applicable corporate and divisional policies, procedures, and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the Statistics function. Responsibly maintain department standards, GxP compliance, and best operating practices. Complete all assigned training on time.
Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff. Responsibilities: Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs. Serve as primary author for statistical sections of protocol. Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells) Participate in development of EDC database and interactive response technology (IxRS) specifications Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions Implement innovative statistical techniques that will provide benefit to Horizon clinical development programs Contribute to strategic planning and go/no go decision guidance Review biostatistics and statistical programming tasks outsourced to vendors Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed Ensure timeliness and quality of deliverables Travel as needed to execute assigned responsibilities and tasks Qualifications and Skills Required: PhD in statistics or related field and at least 3 years of industry experience or MS in statistics or related field and at least 5 years of industry experience. Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically. Proficient in Microsoft Office Professional, proactive demeanor Excellent written and verbal communication skills Experience with people management and development of staff Excellent interpersonal and project management skills Able to collaborate effectively with internal and external study management teams to meet project timelines Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results. Horizon Core Values & Competencies: Growth Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent Accountability Drives Results Ensures Accountability Decision Quality Transparency Courage Collaboration Instills Trust Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.
10/05/2022
Full time
Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff. Responsibilities: Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs. Serve as primary author for statistical sections of protocol. Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells) Participate in development of EDC database and interactive response technology (IxRS) specifications Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions Implement innovative statistical techniques that will provide benefit to Horizon clinical development programs Contribute to strategic planning and go/no go decision guidance Review biostatistics and statistical programming tasks outsourced to vendors Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed Ensure timeliness and quality of deliverables Travel as needed to execute assigned responsibilities and tasks Qualifications and Skills Required: PhD in statistics or related field and at least 3 years of industry experience or MS in statistics or related field and at least 5 years of industry experience. Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically. Proficient in Microsoft Office Professional, proactive demeanor Excellent written and verbal communication skills Experience with people management and development of staff Excellent interpersonal and project management skills Able to collaborate effectively with internal and external study management teams to meet project timelines Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results. Horizon Core Values & Competencies: Growth Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent Accountability Drives Results Ensures Accountability Decision Quality Transparency Courage Collaboration Instills Trust Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.
Amgen is seeking a Corporate Information Technology Audit Senior Manager for our locations in Thousand Oaks, CA or Tampa, FL. This individual contributor will ensure that the Amgen good practice activities are conducted in accordance with regulations, policies and procedures. While reporting to our Director of Corporate IT audit, the Senior Manager will work with the Research and Development and Corporate Quality audit teams across global locations.Key responsibilities as part of this compliance team include: Participating in Internal Process & Service Providers audits to ensure compliance with good practices guidelines, FDA Part 11 regulations and Amgen Standard Operating Procedures Lead or participate in Systems Audits including the development of audit plans, tools, and conduct Detail and summarize auditing results and findings, including recommendations for corrective action or controls for risk mitigation Obtain audit responses from company functions or vendors and evaluate proposed Corrective Action Preventive Action (CAPA) for adequacy if implemented successfully Provide interpretation for internal and external customers on Code of Federal Regulations: Title 21, Part 11, International Conference on Harmonization guidelines for electronic company systems Contribute quality compliance data for metrical analysis Identify matters that require elevation to senior management on mitigation of risk and improving the efficiency of the Compliance Program Travel could include up to 30% domestic and international. Basic Qualifications: Doctorate degree and 2 years of corporate audit experience OR Masters degree and 4 years of corporate audit experience OR Bachelors degree and 6 years corporate audit experience OR Associates degree and 10 years corporate audit experience Or High school diploma / GED and 12 years corporate audit experience Preferred Qualifications: 10+ years of audit or compliance related experience in the biotechnology or pharmaceutical industry, with 5+ years of experience in an IT compliance/validation/quality role Experience in performing or supporting IT system audits or validation activities Proficiency in GxP Guidelines and regulatory requirements for the conduct of clinical trials and manufacturing of pharmaceutical products External audit (Third Party GLP/GCP/GMP vendors) and internal audit experience Knowledge and understanding of the internal control framework Experience with data analytics and data mining skills, including use of current analytical/BI tools for data analysis (Tableau, Spotfire, AMS) Ability to balance multiple activities in a fast-paced environment while delivering a timely and high-quality end work product Self-starter with excellent audit management and communication (both verbal and written) skills, including the ability to effectively and confidentially interact with Amgen senior management Strong interpersonal skills, with ability to forge collaborative relationships with all levels and functions of the organization Ability to prepare and present analytical written and oral communications appropriate for multiple audiences Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
09/14/2021
Full time
Amgen is seeking a Corporate Information Technology Audit Senior Manager for our locations in Thousand Oaks, CA or Tampa, FL. This individual contributor will ensure that the Amgen good practice activities are conducted in accordance with regulations, policies and procedures. While reporting to our Director of Corporate IT audit, the Senior Manager will work with the Research and Development and Corporate Quality audit teams across global locations.Key responsibilities as part of this compliance team include: Participating in Internal Process & Service Providers audits to ensure compliance with good practices guidelines, FDA Part 11 regulations and Amgen Standard Operating Procedures Lead or participate in Systems Audits including the development of audit plans, tools, and conduct Detail and summarize auditing results and findings, including recommendations for corrective action or controls for risk mitigation Obtain audit responses from company functions or vendors and evaluate proposed Corrective Action Preventive Action (CAPA) for adequacy if implemented successfully Provide interpretation for internal and external customers on Code of Federal Regulations: Title 21, Part 11, International Conference on Harmonization guidelines for electronic company systems Contribute quality compliance data for metrical analysis Identify matters that require elevation to senior management on mitigation of risk and improving the efficiency of the Compliance Program Travel could include up to 30% domestic and international. Basic Qualifications: Doctorate degree and 2 years of corporate audit experience OR Masters degree and 4 years of corporate audit experience OR Bachelors degree and 6 years corporate audit experience OR Associates degree and 10 years corporate audit experience Or High school diploma / GED and 12 years corporate audit experience Preferred Qualifications: 10+ years of audit or compliance related experience in the biotechnology or pharmaceutical industry, with 5+ years of experience in an IT compliance/validation/quality role Experience in performing or supporting IT system audits or validation activities Proficiency in GxP Guidelines and regulatory requirements for the conduct of clinical trials and manufacturing of pharmaceutical products External audit (Third Party GLP/GCP/GMP vendors) and internal audit experience Knowledge and understanding of the internal control framework Experience with data analytics and data mining skills, including use of current analytical/BI tools for data analysis (Tableau, Spotfire, AMS) Ability to balance multiple activities in a fast-paced environment while delivering a timely and high-quality end work product Self-starter with excellent audit management and communication (both verbal and written) skills, including the ability to effectively and confidentially interact with Amgen senior management Strong interpersonal skills, with ability to forge collaborative relationships with all levels and functions of the organization Ability to prepare and present analytical written and oral communications appropriate for multiple audiences Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Crescentia Global Talent Solutions
Geyserville, California
The Senior Clinical Research Associate reports to Senior Manager Clinical Research and is responsible for independently managing study activity from site selection and start-up to close out with adherence to regulations, maintaining data integrity and aligning deliverables with corporate goals. Serves as the principal contact person with study sites, for the organization and conduct of pre- and post-market clinical research studies. Collaborates with other staff in the research setting to help encourage best practices in regards to integrity in the study and accuracy and efficiency of data documentation and collection. Initiates and maintains liaison with investigators, site clinical coordinator(s), and regulatory and administrative personnel. Ensures the study is conducted according to GCP and all clinical study related regulations. Responsibilities and Duties:Participate in the development and preparation of study documents such as Protocol, Case Report Forms, Informed Consent, and Subject Questionnaire.Manage IRB submissions and communications throughout the study duration.Record and track clinical trial studies in online government databases. ()Independently perform site qualification, study initiation, site training, interim monitoring and study close-out visits, and complete timely and accurate site visit reports.Manage study sites to ensure enrollment goals are met in accordance with study protocol and timelines.Maintain regular contact and communication with sites (investigators and other personnel) during the course of studies to ensure compliance with the protocol and to identify any issues (e.g., slow enrollment, training, excessive staff turnover, site compliance, etc.).Ensure studies are conducted in accordance with the company SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.Monitor data -- remotely, on site, and via other approved modes with a focus on data integrity (completeness, accuracy and consistency) and patient safety.Ensure CRFs and other study documents are obtained from investigators within timelines.Request any necessary data clarification from investigators. Resolve any data queries/protocol deviations identified within a timely manner.Ensure AEs are recorded and reported accurately and timely as they arise.Create databases and perform accurate data entry within requested timelines.Prepare and maintain the study essential documents including sponsor and site specific regulatory documentation (binders).Develop and maintain study tracking tools and reporting metrics (on study milestones, site payments, subject payments, study data deliverables, etc.) to supervisory staff.Undertake other project related tasks, such as support of the Regulatory Department for submissions and annual updates.Consistently assess clinical research processes and systems for efficiency and compliance.Knowledge and experience of data management and statistical analysis a plus.Other duties as assigned. Education / Training:B.Sc. in the life sciences or allied health/medical related field, or equivalent experience.Two years of experience as a Clinical Research Associate, which includes independent on-site monitoring experience from site qualification and study start up through close out.Two through five years of experience in a clinical research environment, preferably in medical device and/or dermatology or aesthetic space, that includes hands-on site management for clinical trials.Knowledge of GCP guidelines, medical terminology and clinical trial processes required.Proficient in the use of Microsoft Office Applications (Word, Excel, PowerPoint, etc.) Other Requirements: Strong interpersonal and organizational skills.Excellent oral and written communication skills.Strong organizational skills with attention to details.Knowledge of applicable Quality System StandardsSelf-motivated, flexible, and independent thinker.Ability to work in a fast-paced/demanding environment.Problem solver, ability to prioritize and/or multi-taskCollaborative team memberMust be willing to work on-site at corporate headquarters (Monday through Friday).Travel up to 30 percent of the time.
08/31/2021
Full time
The Senior Clinical Research Associate reports to Senior Manager Clinical Research and is responsible for independently managing study activity from site selection and start-up to close out with adherence to regulations, maintaining data integrity and aligning deliverables with corporate goals. Serves as the principal contact person with study sites, for the organization and conduct of pre- and post-market clinical research studies. Collaborates with other staff in the research setting to help encourage best practices in regards to integrity in the study and accuracy and efficiency of data documentation and collection. Initiates and maintains liaison with investigators, site clinical coordinator(s), and regulatory and administrative personnel. Ensures the study is conducted according to GCP and all clinical study related regulations. Responsibilities and Duties:Participate in the development and preparation of study documents such as Protocol, Case Report Forms, Informed Consent, and Subject Questionnaire.Manage IRB submissions and communications throughout the study duration.Record and track clinical trial studies in online government databases. ()Independently perform site qualification, study initiation, site training, interim monitoring and study close-out visits, and complete timely and accurate site visit reports.Manage study sites to ensure enrollment goals are met in accordance with study protocol and timelines.Maintain regular contact and communication with sites (investigators and other personnel) during the course of studies to ensure compliance with the protocol and to identify any issues (e.g., slow enrollment, training, excessive staff turnover, site compliance, etc.).Ensure studies are conducted in accordance with the company SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.Monitor data -- remotely, on site, and via other approved modes with a focus on data integrity (completeness, accuracy and consistency) and patient safety.Ensure CRFs and other study documents are obtained from investigators within timelines.Request any necessary data clarification from investigators. Resolve any data queries/protocol deviations identified within a timely manner.Ensure AEs are recorded and reported accurately and timely as they arise.Create databases and perform accurate data entry within requested timelines.Prepare and maintain the study essential documents including sponsor and site specific regulatory documentation (binders).Develop and maintain study tracking tools and reporting metrics (on study milestones, site payments, subject payments, study data deliverables, etc.) to supervisory staff.Undertake other project related tasks, such as support of the Regulatory Department for submissions and annual updates.Consistently assess clinical research processes and systems for efficiency and compliance.Knowledge and experience of data management and statistical analysis a plus.Other duties as assigned. Education / Training:B.Sc. in the life sciences or allied health/medical related field, or equivalent experience.Two years of experience as a Clinical Research Associate, which includes independent on-site monitoring experience from site qualification and study start up through close out.Two through five years of experience in a clinical research environment, preferably in medical device and/or dermatology or aesthetic space, that includes hands-on site management for clinical trials.Knowledge of GCP guidelines, medical terminology and clinical trial processes required.Proficient in the use of Microsoft Office Applications (Word, Excel, PowerPoint, etc.) Other Requirements: Strong interpersonal and organizational skills.Excellent oral and written communication skills.Strong organizational skills with attention to details.Knowledge of applicable Quality System StandardsSelf-motivated, flexible, and independent thinker.Ability to work in a fast-paced/demanding environment.Problem solver, ability to prioritize and/or multi-taskCollaborative team memberMust be willing to work on-site at corporate headquarters (Monday through Friday).Travel up to 30 percent of the time.
Summary We are currently seeking a Senior Manager, Regulatory Affairs experienced in regulatory affairs. The incumbent is responsible for supporting regulatory strategy and planning activities associated with assigned programs. Activities include managing submissions, managing, and coordinating engagements with Health Authorities, managing responses to health authority queries, and liaising with CROs. Efficiency and effectiveness in delivering the work products are critical to success in the job. The position will report to the program-specific Global Regulatory Lead. Responsibilities Develop and implement tactics to facilitate the creation, review and approval of regulatory documents supporting clinical development activities leading to marketing application submission, review and approval Coordinate and facilitate planning and execution of team engagements with health authorities, including meetings and all correspondence Review technical reports and summary documents for submission to FDA and global health authorities (e.g., clinical protocols and study reports; investigator brochures, pharmacology & toxicology reports, DSURs) for adherence to regulatory guidelines, strategies, and commitments Coordinate and administer work processes within the company's electronic document management system (EDMS) that lead to approval of documentation intended for regulatory submission Coordinate with contract research organizations (CROs) to ensure provision of documents supporting clinical trials and submission activities in countries outside the US Familiarity with the interpretation of applicable FDA, Canadian, EU, PMDA and ICH guidelines related to clinical trial and marketing applications Provide and manage tactical regulatory plans supporting program team goals Lead, manage, and coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation for inclusion in submissions to health authorities Provide advice to authors on the interpretation of templates (including internal and external regulatory guidelines) and the content of modules Draft regulatory documentation from approved sources. Review regulatory documentation for consistency and compliance with guidelines Prepare data for inclusion in regulatory submissions supporting development activities, including NDAs, INDs, IMPDs, QOSs (Canada), CTAs and DSURs Author and review forms supporting information in INDs and CTAs Coordinate responses to questions from health authorities Other duties as assigned or required Qualifications BS or higher level degree in a science-related discipline Minimum of 8 years' experience in a regulatory function in the pharmaceutical/biotechnology industry Experience in producing development (IND/CTA) and marketing applications (NDA/MAA) in eCTD format for global health authority submissions Knowledge of product development activities, including non-clinical studies, clinical trials, and manufacturing NDA/MAA preparation and/or commercialization experience preferred Strong leadership, organization, and prioritization skills Excellent analytical and project planning skills Exceptional written and verbal communication skills Proven ability to manage in a matrix environment and to work collaboratively across all levels of the organization Working knowledge of an EDMS Highly proficient in Word, Excel, PowerPoint, Microsoft Project, and SharePoint; experience with Smartsheet is helpful Travel up to 10% (when COVID restrictions are lifted)
03/10/2021
Full time
Summary We are currently seeking a Senior Manager, Regulatory Affairs experienced in regulatory affairs. The incumbent is responsible for supporting regulatory strategy and planning activities associated with assigned programs. Activities include managing submissions, managing, and coordinating engagements with Health Authorities, managing responses to health authority queries, and liaising with CROs. Efficiency and effectiveness in delivering the work products are critical to success in the job. The position will report to the program-specific Global Regulatory Lead. Responsibilities Develop and implement tactics to facilitate the creation, review and approval of regulatory documents supporting clinical development activities leading to marketing application submission, review and approval Coordinate and facilitate planning and execution of team engagements with health authorities, including meetings and all correspondence Review technical reports and summary documents for submission to FDA and global health authorities (e.g., clinical protocols and study reports; investigator brochures, pharmacology & toxicology reports, DSURs) for adherence to regulatory guidelines, strategies, and commitments Coordinate and administer work processes within the company's electronic document management system (EDMS) that lead to approval of documentation intended for regulatory submission Coordinate with contract research organizations (CROs) to ensure provision of documents supporting clinical trials and submission activities in countries outside the US Familiarity with the interpretation of applicable FDA, Canadian, EU, PMDA and ICH guidelines related to clinical trial and marketing applications Provide and manage tactical regulatory plans supporting program team goals Lead, manage, and coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation for inclusion in submissions to health authorities Provide advice to authors on the interpretation of templates (including internal and external regulatory guidelines) and the content of modules Draft regulatory documentation from approved sources. Review regulatory documentation for consistency and compliance with guidelines Prepare data for inclusion in regulatory submissions supporting development activities, including NDAs, INDs, IMPDs, QOSs (Canada), CTAs and DSURs Author and review forms supporting information in INDs and CTAs Coordinate responses to questions from health authorities Other duties as assigned or required Qualifications BS or higher level degree in a science-related discipline Minimum of 8 years' experience in a regulatory function in the pharmaceutical/biotechnology industry Experience in producing development (IND/CTA) and marketing applications (NDA/MAA) in eCTD format for global health authority submissions Knowledge of product development activities, including non-clinical studies, clinical trials, and manufacturing NDA/MAA preparation and/or commercialization experience preferred Strong leadership, organization, and prioritization skills Excellent analytical and project planning skills Exceptional written and verbal communication skills Proven ability to manage in a matrix environment and to work collaboratively across all levels of the organization Working knowledge of an EDMS Highly proficient in Word, Excel, PowerPoint, Microsoft Project, and SharePoint; experience with Smartsheet is helpful Travel up to 10% (when COVID restrictions are lifted)
BLH Technologies, Inc., an award-winning company specializing in public health, communications, technology, and safety monitoring solutions for federal and commercial clients, is seeking a Senior Project Manager to support federal clients, including those within the National Institutes of Health (NIH). The desired staff member will work in cooperation with our BLH team and government clients to develop cloud-based systems for biomedical research repositories. Duties Develop and maintain project management plans, documents, and artifacts to coordinate between client and supporting developers, programmers, and subject matter expert staff. Perform client-facing management duties including communications, facilitation of meetings, collection, and defining requirements. Maintain project budget and forecasts. Participate on BLH and client teams to define future related projects that help drive client goals. Work with the BLH business development team to identify future business opportunities and work on team to draft white papers and proposals. Oversee the development of a government web-based system for collecting and organizing biomedical research information, including clinical trial information. Develop transformational metadata crosswalks and pipelines to facilitate the ingestion of descriptive metadata from select repositories. Set up a cloud-based metadata storage backend to accommodate RDF data (e.g., Triplestore) Develop, test, and refine Search Graphical User Interface (GUI) including implementing searching and analytics on RDF data. Qualifications Ph.D. or Master's degree in Biology or a related field is preferred. Minimum of 10 years' full-time experience performing similar tasks. Demonstrated ability to manage others and meet client goals. Preference with experience supporting federal health projects. Demonstrated ability to work with government, contractor, and academic organizations. Experience with academic organizations is strongly preferred. Knowledge of clinical trials, data, and government policies and procedures for the flow of clinical data through trial phases and submission of data to government databases. Preference for project management, Agile management, or related Scrum certification. Previous experience managing large, complex databases, form-entry systems, metadata, and integration of software technologies. Preference for experience in working with research and/or biomedical repositories. Demonstrated experience in leading and managing a team to support and/or develop complex cloud-based web and database solutions. Previous experience with federal government support preferred. NIH development experience preferred. Knowledge and Special Skills Strong communication and collaboration skills (written, oral, and interpersonal). Understanding of and experience in writing user case scenarios. Must be extremely detail-oriented. Must be a critical thinker with the ability to assimilate and convey complex information in plain language, tailored to different audiences. Ability to multitask and set priorities to meet deadlines.
01/30/2021
Full time
BLH Technologies, Inc., an award-winning company specializing in public health, communications, technology, and safety monitoring solutions for federal and commercial clients, is seeking a Senior Project Manager to support federal clients, including those within the National Institutes of Health (NIH). The desired staff member will work in cooperation with our BLH team and government clients to develop cloud-based systems for biomedical research repositories. Duties Develop and maintain project management plans, documents, and artifacts to coordinate between client and supporting developers, programmers, and subject matter expert staff. Perform client-facing management duties including communications, facilitation of meetings, collection, and defining requirements. Maintain project budget and forecasts. Participate on BLH and client teams to define future related projects that help drive client goals. Work with the BLH business development team to identify future business opportunities and work on team to draft white papers and proposals. Oversee the development of a government web-based system for collecting and organizing biomedical research information, including clinical trial information. Develop transformational metadata crosswalks and pipelines to facilitate the ingestion of descriptive metadata from select repositories. Set up a cloud-based metadata storage backend to accommodate RDF data (e.g., Triplestore) Develop, test, and refine Search Graphical User Interface (GUI) including implementing searching and analytics on RDF data. Qualifications Ph.D. or Master's degree in Biology or a related field is preferred. Minimum of 10 years' full-time experience performing similar tasks. Demonstrated ability to manage others and meet client goals. Preference with experience supporting federal health projects. Demonstrated ability to work with government, contractor, and academic organizations. Experience with academic organizations is strongly preferred. Knowledge of clinical trials, data, and government policies and procedures for the flow of clinical data through trial phases and submission of data to government databases. Preference for project management, Agile management, or related Scrum certification. Previous experience managing large, complex databases, form-entry systems, metadata, and integration of software technologies. Preference for experience in working with research and/or biomedical repositories. Demonstrated experience in leading and managing a team to support and/or develop complex cloud-based web and database solutions. Previous experience with federal government support preferred. NIH development experience preferred. Knowledge and Special Skills Strong communication and collaboration skills (written, oral, and interpersonal). Understanding of and experience in writing user case scenarios. Must be extremely detail-oriented. Must be a critical thinker with the ability to assimilate and convey complex information in plain language, tailored to different audiences. Ability to multitask and set priorities to meet deadlines.
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
01/28/2021
Full time
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad- spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of-concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX- XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team. Candidate should be an experienced and flexible individual who would be comfortable working on multiple tasks at once, with excellent communication skills to navigate rapid changes in prioritization. This position is for a scientific role which will be primarily lab based. The candidate will have a good knowledge and practical experience in the field of vaccine formulation. The candidate will also have industry based experience in a range of standard protein biochemistry analytical techniques. Experience in biophysical characterization of formulations would be very beneficial. The primary responsibility for the incumbent will be to support development of projects from the research through the preclinical phase, into early clinical phases and also supporting later stage programs. Essential Functions: • Supporting formulation manufacture for thermal, freeze/thaw, and agitation stability studies on both Drug Substance (DS) and Drug Product (DP) materials • Conducting analysis of these formulations using a broad range of standard protein biochemistry analytical techniques for formulation selection • Supporting formulation comparability studies, container selection and scale up activities • Preparing sterile formulation samples to be used for in vivo testing • Evaluating effect of new formulation components on already established standard analytical assays • Maintaining an accurate and up to date inventory of supplies of DS used by multiple groups Requirements: • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, or Analytical Chemistry or Biology considered, with >2years of industrial experience • The candidate will have had previous experience in developing formulation of proteins, polysaccharides and/or protein conjugates for adjuvant containing vaccines (other biological experience also considered) • Experience supporting stability studies, including study set up and sample testing and analysis • Experience in using standard protein plate based assays is needed. Some experience in spectrometric methodologies, particle light scattering, quantitative subvisible particle analysis, visible analysis and HPLC/UV is preferred • Experience working under aseptic conditions is necessary • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team • Critical thinking, the ability to analyse data and to report results to the team in a clear and concise manner during group meetings is needed • Eagerness, ability to learn and great flexibility to rapidly switch gears between tasks • Detail oriented, rigorous and excellent skills in record keeping/documentation • Good proficiency in the use of Microsoft office suite (in particular Excel and PowerPoint) Reports to: Senior Scientist in the Formulation and Drug Product Development team Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/27/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad- spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of-concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX- XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team. Candidate should be an experienced and flexible individual who would be comfortable working on multiple tasks at once, with excellent communication skills to navigate rapid changes in prioritization. This position is for a scientific role which will be primarily lab based. The candidate will have a good knowledge and practical experience in the field of vaccine formulation. The candidate will also have industry based experience in a range of standard protein biochemistry analytical techniques. Experience in biophysical characterization of formulations would be very beneficial. The primary responsibility for the incumbent will be to support development of projects from the research through the preclinical phase, into early clinical phases and also supporting later stage programs. Essential Functions: • Supporting formulation manufacture for thermal, freeze/thaw, and agitation stability studies on both Drug Substance (DS) and Drug Product (DP) materials • Conducting analysis of these formulations using a broad range of standard protein biochemistry analytical techniques for formulation selection • Supporting formulation comparability studies, container selection and scale up activities • Preparing sterile formulation samples to be used for in vivo testing • Evaluating effect of new formulation components on already established standard analytical assays • Maintaining an accurate and up to date inventory of supplies of DS used by multiple groups Requirements: • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, or Analytical Chemistry or Biology considered, with >2years of industrial experience • The candidate will have had previous experience in developing formulation of proteins, polysaccharides and/or protein conjugates for adjuvant containing vaccines (other biological experience also considered) • Experience supporting stability studies, including study set up and sample testing and analysis • Experience in using standard protein plate based assays is needed. Some experience in spectrometric methodologies, particle light scattering, quantitative subvisible particle analysis, visible analysis and HPLC/UV is preferred • Experience working under aseptic conditions is necessary • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team • Critical thinking, the ability to analyse data and to report results to the team in a clear and concise manner during group meetings is needed • Eagerness, ability to learn and great flexibility to rapidly switch gears between tasks • Detail oriented, rigorous and excellent skills in record keeping/documentation • Good proficiency in the use of Microsoft office suite (in particular Excel and PowerPoint) Reports to: Senior Scientist in the Formulation and Drug Product Development team Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
The Senior Director, Clinical Sciences will support conduct of clinical studies, primarily with therapeutic antibodies and antibody-like compounds, and will play a key leadership role in clinical development programs, including being accountable for deliverables of the assigned program(s), resourcing, budget and timelines. Serves as Scientific and Medical Lead for Clinical team(s) working closely with operational leads- Clinical Therapeutic Area Project Manager and Clinical Trial Manager(s) for each indication/study, and with Therapeutic Area Program Manager(s) who serve as operational program lead(s) for programs within each respective TA. May assume leadership responsibility for a large section/indication of a development plan, or an entire asset development plan. The incumbent will provide strategic scientific and clinical foresight, insight, and oversight for therapeutic candidates about to enter and already in clinical experiments, and s/he will collaborate with the corporate partner clinical teams, providing medical and scientific support for the programs and communication with the medical community, establishing Regeneron as a key and competitive player. S/he will also work effectively with regulatory agencies both in the U.S. and internationally. A day in the life of a Senior Medical Director may include the following responsibilities: • Deliver high quality program deliverables on time and within budget. Collaborate with external partners, including pharmaceutical companies and contract research organizations (CROs), in producing effective, efficient, and rapid clinical development programs. • Manage, track and troubleshoot series of related trials within programs. • Identify program risks; proactively create and implement mitigation strategies. • Develop objectives and ensure that program goals are met. • Lead work plans and provide clinical research direction. • Develop and apply strategies to identify research opportunities. • Work in a multidisciplinary management team with internal and external partners; direct activities of groups in multiple disciplines. • Work effectively with regulatory agencies both in the US and internationally. . • Utilize complete functional knowledge and awareness of Company goals and objectives in the planning and execution of clinical trials and in the interpretation of study results. • Develop or review key study documents, including research protocols, study reports, clinical portions of regulatory documents, publications and formal and informal presentations of study data. • Participate in professional development activities to keep abreast of developments in areas under study. Such activities may include meeting and seminar attendance, reading of scientific publications, etc. • Contribute to related publications, abstracts and other forms of public communication presented • Supervise/mentor less experienced members of the development team In order to be considered for this role you must have an M.D. degree with strong preference for specialized clinical training in allergy & immunology or pulmonology/respiratory with a minimum of 6+ years of relevant industry experience. #LI-SC1, SK Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-SC1
01/25/2021
Full time
The Senior Director, Clinical Sciences will support conduct of clinical studies, primarily with therapeutic antibodies and antibody-like compounds, and will play a key leadership role in clinical development programs, including being accountable for deliverables of the assigned program(s), resourcing, budget and timelines. Serves as Scientific and Medical Lead for Clinical team(s) working closely with operational leads- Clinical Therapeutic Area Project Manager and Clinical Trial Manager(s) for each indication/study, and with Therapeutic Area Program Manager(s) who serve as operational program lead(s) for programs within each respective TA. May assume leadership responsibility for a large section/indication of a development plan, or an entire asset development plan. The incumbent will provide strategic scientific and clinical foresight, insight, and oversight for therapeutic candidates about to enter and already in clinical experiments, and s/he will collaborate with the corporate partner clinical teams, providing medical and scientific support for the programs and communication with the medical community, establishing Regeneron as a key and competitive player. S/he will also work effectively with regulatory agencies both in the U.S. and internationally. A day in the life of a Senior Medical Director may include the following responsibilities: • Deliver high quality program deliverables on time and within budget. Collaborate with external partners, including pharmaceutical companies and contract research organizations (CROs), in producing effective, efficient, and rapid clinical development programs. • Manage, track and troubleshoot series of related trials within programs. • Identify program risks; proactively create and implement mitigation strategies. • Develop objectives and ensure that program goals are met. • Lead work plans and provide clinical research direction. • Develop and apply strategies to identify research opportunities. • Work in a multidisciplinary management team with internal and external partners; direct activities of groups in multiple disciplines. • Work effectively with regulatory agencies both in the US and internationally. . • Utilize complete functional knowledge and awareness of Company goals and objectives in the planning and execution of clinical trials and in the interpretation of study results. • Develop or review key study documents, including research protocols, study reports, clinical portions of regulatory documents, publications and formal and informal presentations of study data. • Participate in professional development activities to keep abreast of developments in areas under study. Such activities may include meeting and seminar attendance, reading of scientific publications, etc. • Contribute to related publications, abstracts and other forms of public communication presented • Supervise/mentor less experienced members of the development team In order to be considered for this role you must have an M.D. degree with strong preference for specialized clinical training in allergy & immunology or pulmonology/respiratory with a minimum of 6+ years of relevant industry experience. #LI-SC1, SK Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-SC1
Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support its expanding cellular therapy programs. The Senior Manager / Manager, Regulatory Affairs (RA) will provide support to the Vice President, RA in the development and implementation of regulatory strategies for development products. This role is responsible for executing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to cellular therapies in clinical development. This role will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to cell therapies. This is a full-time position located at our corporate headquarters in San Diego, CA. Responsibilities • Serve as a RA CMC representative on project teams and provide regulatory expertise and input on cross-functional team recommendations to facilitate successful product development globally. • Support CMC teams to develop global submission plans that comply with local regulatory requirements and commitments. • Author and/or lead the preparation of regulatory dossiers for submission to global Health Authorities throughout the product lifecycle. • Effectively and thoughtfully communicate with Health Authorities while maintaining good rapport and credibility. When appropriate lead meetings with Health Authorities under supervision of a senior member of the RA Department. Develop and reach consensus on regulatory CMC strategy for Health Authority information request responses, as needed. • Provide accurate regulatory assessments of CMC changes to project teams and refine regulatory strategies as needed based on emerging data, therapeutic area, and evolving regulatory landscape. • Drive a corporate culture of continuous improvement to ensure compliance with Health Authority laws and recommendations, as well as industry best practices. • Develop and update contingency plans for issues that may affect product registration, regulatory compliance, and the continued lifecycle management of development products. • Escalate issues to Regulatory Management that may affect registration, regulatory compliance and continued lifecycle management of the product. • May lead selected initiatives within the Regulatory Department and/or provide oversight of assigned staff. Requirements • A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering sciences with generally a minimum of 3+ years of experience in the pharmaceutical or health care industry is required. An MS, PhD, or PharmD. degree preferred. • Experience in biologics is preferred. • Strong knowledge of global Health Authority laws, regulations, guidance and regulation submission routes available for assigned products is required. • Strong experience directly writing submission documents that support clinical trials, marketing, and lifecycle management is required. • Experience in regulations or product development in gene therapy (i.e., CAR-Ts, AAVs, CRISPR technology etc.) is preferred. • Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required. • Strong attention to detail with high-level verbal and written communication skills is required; effectively communicates cross-functionally. Ability to present and defend regulatory strategies and opinions to project teams. • Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly. • High attention to detail, ability to work on multiple projects with tight deadlines, and able to work independently. • Demonstrates clear understanding of priorities and leads others by example to drive for results. • Good understanding of competitors in the area and what they are doing in early/late development is preferred. Working Conditions and Physical Requirements • May require occasional evening and weekend work • Full-time onsite work at Company's headquarters in San Diego • May require occasional travel for training programs and meetings The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: and reference job 379JB. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid- derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit .
01/25/2021
Full time
Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support its expanding cellular therapy programs. The Senior Manager / Manager, Regulatory Affairs (RA) will provide support to the Vice President, RA in the development and implementation of regulatory strategies for development products. This role is responsible for executing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to cellular therapies in clinical development. This role will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to cell therapies. This is a full-time position located at our corporate headquarters in San Diego, CA. Responsibilities • Serve as a RA CMC representative on project teams and provide regulatory expertise and input on cross-functional team recommendations to facilitate successful product development globally. • Support CMC teams to develop global submission plans that comply with local regulatory requirements and commitments. • Author and/or lead the preparation of regulatory dossiers for submission to global Health Authorities throughout the product lifecycle. • Effectively and thoughtfully communicate with Health Authorities while maintaining good rapport and credibility. When appropriate lead meetings with Health Authorities under supervision of a senior member of the RA Department. Develop and reach consensus on regulatory CMC strategy for Health Authority information request responses, as needed. • Provide accurate regulatory assessments of CMC changes to project teams and refine regulatory strategies as needed based on emerging data, therapeutic area, and evolving regulatory landscape. • Drive a corporate culture of continuous improvement to ensure compliance with Health Authority laws and recommendations, as well as industry best practices. • Develop and update contingency plans for issues that may affect product registration, regulatory compliance, and the continued lifecycle management of development products. • Escalate issues to Regulatory Management that may affect registration, regulatory compliance and continued lifecycle management of the product. • May lead selected initiatives within the Regulatory Department and/or provide oversight of assigned staff. Requirements • A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering sciences with generally a minimum of 3+ years of experience in the pharmaceutical or health care industry is required. An MS, PhD, or PharmD. degree preferred. • Experience in biologics is preferred. • Strong knowledge of global Health Authority laws, regulations, guidance and regulation submission routes available for assigned products is required. • Strong experience directly writing submission documents that support clinical trials, marketing, and lifecycle management is required. • Experience in regulations or product development in gene therapy (i.e., CAR-Ts, AAVs, CRISPR technology etc.) is preferred. • Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required. • Strong attention to detail with high-level verbal and written communication skills is required; effectively communicates cross-functionally. Ability to present and defend regulatory strategies and opinions to project teams. • Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly. • High attention to detail, ability to work on multiple projects with tight deadlines, and able to work independently. • Demonstrates clear understanding of priorities and leads others by example to drive for results. • Good understanding of competitors in the area and what they are doing in early/late development is preferred. Working Conditions and Physical Requirements • May require occasional evening and weekend work • Full-time onsite work at Company's headquarters in San Diego • May require occasional travel for training programs and meetings The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: and reference job 379JB. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid- derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit .
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
As a Temp Senior Clinical Study Lead (SCSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a SCSL who has experience managing Third-Party Vendors. We need someone who can also contribute to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market. A typical day might include the following: Providing operational input into protocol development Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensuring compliance with the clinical trial registry requirements Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results Leading risk assessment and identifies risk mitigation strategies at the study level Running feasibility assessment to select relevant regions and countries for the study Conducting site evaluation and selection Leading investigator meeting preparation and execution Monitoring progress for site activation and monitoring visits and acts on any deviations from plan Handling development and implementation of patient recruitment and patient retention strategies Monitoring data entry and query resolution and taking action on any divergence from agreed metrics Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required Supervising study close-out activities and contributing to clinical study report writing and review This role might be for you if: You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies You can take a proactive and self-disciplined approach to managing projects with a developed ability to meet deadlines and prioritize You have a history of effectively leading and negotiating with vendors You have a data-driven approach to planning, executing and problem solving You operate with a high degree of cross-functional agility using exceptional influencing and interpersonal skills You have the innate ability to rally disparate groups to accomplish lofty shared goals To be considered for this opportunity you must possess a Bachelors' degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
01/25/2021
Full time
As a Temp Senior Clinical Study Lead (SCSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a SCSL who has experience managing Third-Party Vendors. We need someone who can also contribute to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market. A typical day might include the following: Providing operational input into protocol development Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensuring compliance with the clinical trial registry requirements Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results Leading risk assessment and identifies risk mitigation strategies at the study level Running feasibility assessment to select relevant regions and countries for the study Conducting site evaluation and selection Leading investigator meeting preparation and execution Monitoring progress for site activation and monitoring visits and acts on any deviations from plan Handling development and implementation of patient recruitment and patient retention strategies Monitoring data entry and query resolution and taking action on any divergence from agreed metrics Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required Supervising study close-out activities and contributing to clinical study report writing and review This role might be for you if: You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies You can take a proactive and self-disciplined approach to managing projects with a developed ability to meet deadlines and prioritize You have a history of effectively leading and negotiating with vendors You have a data-driven approach to planning, executing and problem solving You operate with a high degree of cross-functional agility using exceptional influencing and interpersonal skills You have the innate ability to rally disparate groups to accomplish lofty shared goals To be considered for this opportunity you must possess a Bachelors' degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
Myovant Sciences, Ltd. (NYSE: MYOV) aspires to be the leading healthcare company focused on redefining care for women's health and prostate cancer. Myovant Sciences' lead product candidate is relugolix, an oral, once-a day small molecule that acts as a GnRH receptor antagonist. The company has three clinical programs for relugolix consisting of five international Phase 3 clinical trials, two in women with heavy menstrual bleeding associated with uterine fibroids (LIBERTY 1 & 2), two in women with endometriosis-associated pain (SPIRIT 1 & 2), and one in men with advanced prostate cancer (HERO). Positive results have been announced for four of the five trials, with the final trial results to be released in mid-2020. Two New Drug Applications have been submitted to the FDA, including one for relugolix for men with advanced prostate cancer in April 2020, which was approved in December 2020 and one for relugolix combination tablet for women with heavy menstrual bleeding and uterine fibroids in May 2020. In January 2021 Myovant has launched ORGOVYX™ (relugolix), the first and only oral gonadotropin-Releasing Hormone (GnRH) receptor antagonist for Advanced Prostate Cancer, while continuing to prepare for potential commercial launches in the U.S. for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids and for women with pain associated with endometriosis, in anticipation of FDA approval to market in these indications. Recently, Myovant also announced a collaboration with Pfizer to develop and Commercialize relugolix in Oncology and Women's Health, which substantially enhancing the financial position of Myovant and enabling the organization to expand our pipeline of potential new medicines. Myovant is on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission. We are currently seeking qualified, highly motivated, experiences individual for the position of Director/ Senior Director, Human Resources Business Partner. This position will report to the Senior Vice President, Human Resources and be a member of the Human Resources leadership team. The location of the position is in Brisbane, CA. Summary Description The Director/ Senior Director, Human Resources Business Partner is an integral member of the HR team, and will be a trusted partner helping to drive critical results. This role will be instrumental in shaping our culture, supporting our business strategies, and developing our talent pipeline. Be the ambassador of the HR organization to represent the services and resources available to the business and help lead the collective reputation of the HR organization. The Director/ Senior Director, HRBP will also be a trusted advisor to executives, managers and employees on organizational and people related issues, including but not limited to workforce planning, organizational design and effectiveness, employee engagement, employee relations, and performance management, to promote and maintain Myovant's collaborative and mission driven culture. Key to this will also be the ability to quickly develop trusted relationships with people at all levels within the organization as well as within the HR team. Essential Duties and Responsibilities Build and cultivate strong partnerships with senior leaders to offer thought leadership on organizational and people-related strategy and execution to ensure a high-performing and engaged workforce. Advise, guide and coach leaders at all levels within Myovant to navigate the complexities of managing teams, performance management, managing career development, developing a high-performance culture, managing employee relations issues and providing conflict resolution strategies, etc. Provide candid feedback about talent moves, gaps, promotions, and growth opportunities. Acts as the lead translator of business needs to the rest of the HR team to help shape company-wide HR systems and solutions. Collaborate with other HR functions (Talent Acquisition, People Operations & Analytics, etc.) in the design and implementation of HR programs to attract, retain and promote a diverse and inclusive workforce. Development and delivery of an effective communication strategy to improve the intent and execution of business results. Regularly maintain awareness and understanding of current regulations, industry trends, current practices, new developments and applicable state and federal employment laws. Strong analytical skills with an emphasis on key insights, trends, issue identification and recommendations. Partners with leaders and their leadership teams to establish and execute a consistent people strategy and plan, supported by a scalable and effective HR infrastructure. Advises business leaders on HR policy and program matters, making or recommending appropriate decisions, which may be significantly complex. Leads the planning, development, implementation, administration, and budgeting for HR within assigned client groups. Partner with HR team members on key HR initiatives including compensation, recruitment, training and development. Provides advice and feedback regarding the design and rollout. Conduct and/or facilitate new hire onboarding meetings, exit interviews, annual talent/performance review related meetings. Manages complex employment relations issues in partnership with Legal Identifies opportunities to expand and strengthen the HRBP's role in supporting client's organization. Strong problem-solving aptitude, creative, flexible and consultative; strong sense of business needs and making decisions based on data and emerging priorities; high integrity and accountability. Ability to listen and use critical thinking to assess the needs and communicate accurate information concerning process, plans and procedures in a collaborative, team-based manner. Detail-oriented, proven ability to track, prioritize and drive to success multiple concurrent projects by analyzing data and driving sound decision-making. Thrives in and enjoys a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment. Core Competencies, Knowledge, and Skill Requirements Leads with a global mindset and enterprise perspective, takes into consideration how decisions impact other parts of the organization/function, strives towards integrated solutions to maximize impact on business. Thrives at dealing with high level of ambiguity and complexity, highly adaptable to different situations and agile in response, guides/supports the team/function in time of change. Excellent verbal, written, and interpersonal communication skills are required. Must possess strong ability to influence at all levels. Connects across the company to build strong relationships with functional partners. Keen insight and understanding of business objectives with the ability to translate those objectives into HR priorities. Requires a thorough knowledge and understanding of Human Resources legislation/employment law, principles, policies, and procedures. Must be able to develop solutions to a wide range of highly complex problems, which require an in-depth degree of urgency, engagement, and innovation. Ability to exercise judgment and independently determine and take appropriate action within defined HR policies and procedures. Is a champion, coach and mentor for the development of others. Consistently demonstrates a positive, 'can do' and service-oriented attitude. Strong oral and written communicator; detail oriented with a commitment to accuracy. Must be comfortable with challenging the status quo in a growing team, influencing senior leaders, and be very comfortable with toggling back and forth between excellent tactical execution and making sure there is a sound and longer-term strategy behind all our work and the solutions. REQUIREMENTS Education BA or BS degree, preferably with an emphasis in HR or Business. A Master's degree can be substituted for 2 years of relevant experience. Experience 12+ years of relevant experience in the HR field with a minimum of 10 years as an HRBP. Must have experience working with and influencing senior management, technical leaders, and technical staff in the biotech/pharmaceutical sectors. Must know and understand the drug development business and/or commercial business. Preferred experience with training and leadership development in creating strategy, implementing, and tracking of leadership programs (i.e. succession planning, leadership development, training programs. Extensive experience influencing business leaders individually and collectively. Must be comfortable to propose solutions others are reluctant to address, act in the face of resistance and advocate for the best interests of the organization. A strategic mindset but can also focus on tactical and operational issues. Must be comfortable rolling up your sleeves to get things done and the next moment being part of deeply complex strategic discussions. Demonstrable skills in business insight, collaborating, analysis, project management, communication, presentation, negotiation, conflict management and problem solving. Must be very detail oriented and have excellent analytical and problem-solving skills...... click apply for full job details
01/21/2021
Full time
Myovant Sciences, Ltd. (NYSE: MYOV) aspires to be the leading healthcare company focused on redefining care for women's health and prostate cancer. Myovant Sciences' lead product candidate is relugolix, an oral, once-a day small molecule that acts as a GnRH receptor antagonist. The company has three clinical programs for relugolix consisting of five international Phase 3 clinical trials, two in women with heavy menstrual bleeding associated with uterine fibroids (LIBERTY 1 & 2), two in women with endometriosis-associated pain (SPIRIT 1 & 2), and one in men with advanced prostate cancer (HERO). Positive results have been announced for four of the five trials, with the final trial results to be released in mid-2020. Two New Drug Applications have been submitted to the FDA, including one for relugolix for men with advanced prostate cancer in April 2020, which was approved in December 2020 and one for relugolix combination tablet for women with heavy menstrual bleeding and uterine fibroids in May 2020. In January 2021 Myovant has launched ORGOVYX™ (relugolix), the first and only oral gonadotropin-Releasing Hormone (GnRH) receptor antagonist for Advanced Prostate Cancer, while continuing to prepare for potential commercial launches in the U.S. for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids and for women with pain associated with endometriosis, in anticipation of FDA approval to market in these indications. Recently, Myovant also announced a collaboration with Pfizer to develop and Commercialize relugolix in Oncology and Women's Health, which substantially enhancing the financial position of Myovant and enabling the organization to expand our pipeline of potential new medicines. Myovant is on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission. We are currently seeking qualified, highly motivated, experiences individual for the position of Director/ Senior Director, Human Resources Business Partner. This position will report to the Senior Vice President, Human Resources and be a member of the Human Resources leadership team. The location of the position is in Brisbane, CA. Summary Description The Director/ Senior Director, Human Resources Business Partner is an integral member of the HR team, and will be a trusted partner helping to drive critical results. This role will be instrumental in shaping our culture, supporting our business strategies, and developing our talent pipeline. Be the ambassador of the HR organization to represent the services and resources available to the business and help lead the collective reputation of the HR organization. The Director/ Senior Director, HRBP will also be a trusted advisor to executives, managers and employees on organizational and people related issues, including but not limited to workforce planning, organizational design and effectiveness, employee engagement, employee relations, and performance management, to promote and maintain Myovant's collaborative and mission driven culture. Key to this will also be the ability to quickly develop trusted relationships with people at all levels within the organization as well as within the HR team. Essential Duties and Responsibilities Build and cultivate strong partnerships with senior leaders to offer thought leadership on organizational and people-related strategy and execution to ensure a high-performing and engaged workforce. Advise, guide and coach leaders at all levels within Myovant to navigate the complexities of managing teams, performance management, managing career development, developing a high-performance culture, managing employee relations issues and providing conflict resolution strategies, etc. Provide candid feedback about talent moves, gaps, promotions, and growth opportunities. Acts as the lead translator of business needs to the rest of the HR team to help shape company-wide HR systems and solutions. Collaborate with other HR functions (Talent Acquisition, People Operations & Analytics, etc.) in the design and implementation of HR programs to attract, retain and promote a diverse and inclusive workforce. Development and delivery of an effective communication strategy to improve the intent and execution of business results. Regularly maintain awareness and understanding of current regulations, industry trends, current practices, new developments and applicable state and federal employment laws. Strong analytical skills with an emphasis on key insights, trends, issue identification and recommendations. Partners with leaders and their leadership teams to establish and execute a consistent people strategy and plan, supported by a scalable and effective HR infrastructure. Advises business leaders on HR policy and program matters, making or recommending appropriate decisions, which may be significantly complex. Leads the planning, development, implementation, administration, and budgeting for HR within assigned client groups. Partner with HR team members on key HR initiatives including compensation, recruitment, training and development. Provides advice and feedback regarding the design and rollout. Conduct and/or facilitate new hire onboarding meetings, exit interviews, annual talent/performance review related meetings. Manages complex employment relations issues in partnership with Legal Identifies opportunities to expand and strengthen the HRBP's role in supporting client's organization. Strong problem-solving aptitude, creative, flexible and consultative; strong sense of business needs and making decisions based on data and emerging priorities; high integrity and accountability. Ability to listen and use critical thinking to assess the needs and communicate accurate information concerning process, plans and procedures in a collaborative, team-based manner. Detail-oriented, proven ability to track, prioritize and drive to success multiple concurrent projects by analyzing data and driving sound decision-making. Thrives in and enjoys a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment. Core Competencies, Knowledge, and Skill Requirements Leads with a global mindset and enterprise perspective, takes into consideration how decisions impact other parts of the organization/function, strives towards integrated solutions to maximize impact on business. Thrives at dealing with high level of ambiguity and complexity, highly adaptable to different situations and agile in response, guides/supports the team/function in time of change. Excellent verbal, written, and interpersonal communication skills are required. Must possess strong ability to influence at all levels. Connects across the company to build strong relationships with functional partners. Keen insight and understanding of business objectives with the ability to translate those objectives into HR priorities. Requires a thorough knowledge and understanding of Human Resources legislation/employment law, principles, policies, and procedures. Must be able to develop solutions to a wide range of highly complex problems, which require an in-depth degree of urgency, engagement, and innovation. Ability to exercise judgment and independently determine and take appropriate action within defined HR policies and procedures. Is a champion, coach and mentor for the development of others. Consistently demonstrates a positive, 'can do' and service-oriented attitude. Strong oral and written communicator; detail oriented with a commitment to accuracy. Must be comfortable with challenging the status quo in a growing team, influencing senior leaders, and be very comfortable with toggling back and forth between excellent tactical execution and making sure there is a sound and longer-term strategy behind all our work and the solutions. REQUIREMENTS Education BA or BS degree, preferably with an emphasis in HR or Business. A Master's degree can be substituted for 2 years of relevant experience. Experience 12+ years of relevant experience in the HR field with a minimum of 10 years as an HRBP. Must have experience working with and influencing senior management, technical leaders, and technical staff in the biotech/pharmaceutical sectors. Must know and understand the drug development business and/or commercial business. Preferred experience with training and leadership development in creating strategy, implementing, and tracking of leadership programs (i.e. succession planning, leadership development, training programs. Extensive experience influencing business leaders individually and collectively. Must be comfortable to propose solutions others are reluctant to address, act in the face of resistance and advocate for the best interests of the organization. A strategic mindset but can also focus on tactical and operational issues. Must be comfortable rolling up your sleeves to get things done and the next moment being part of deeply complex strategic discussions. Demonstrable skills in business insight, collaborating, analysis, project management, communication, presentation, negotiation, conflict management and problem solving. Must be very detail oriented and have excellent analytical and problem-solving skills...... click apply for full job details
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Senior Manager, Statistics Provide statistical support for development strategy for clinical or scientific research programs. Key Responsibilities: • Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments. Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for sample size estimation. • Independently determine appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization schedule as planned. • Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements. • Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach. • Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. • Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables. • Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans • Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data. • Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area. • Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department standards, GxP compliance, and best operating practices. Qualifications • Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments. Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for sample size estimation. • Independently determine appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization schedule as planned. • Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements. • Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach. • Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. • Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables. • Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans • Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data. • Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area. • Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department standards, GxP compliance, and best operating practices. . Oncology Experience is preferred **Equal Opportunity Employer Minorities/Women/Veterans/Disabled* Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status..... click apply for full job details
01/20/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Senior Manager, Statistics Provide statistical support for development strategy for clinical or scientific research programs. Key Responsibilities: • Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments. Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for sample size estimation. • Independently determine appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization schedule as planned. • Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements. • Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach. • Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. • Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables. • Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans • Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data. • Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area. • Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department standards, GxP compliance, and best operating practices. Qualifications • Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works with project team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments. Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters for sample size estimation. • Independently determine appropriate statistical methodology needed in support of study objectives; develops and authors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works with external partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomization schedule as planned. • Actively participates in meetings to identify scientifically appropriate data collection instruments and database design requirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements. • Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach. • Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. • Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods and relevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables. • Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans • Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data. • Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area. • Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics department standards, GxP compliance, and best operating practices. . Oncology Experience is preferred **Equal Opportunity Employer Minorities/Women/Veterans/Disabled* Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status..... click apply for full job details
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
01/15/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Senior Clinical Data Manager, with demonstrated experience in clinical trials, to work onsite with the National Institutes of Health in Rockville, MD. This is a long-term contract position which offers: - Competitive salary with comprehensive benefit package - Opportunity to work at NIH, the world's foremost medical research center - Learn more about what Kelly can do for you at TASKS: The contractor shall: Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs. Provide technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures. Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs. Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing. Conducts data reviews. Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards. Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing) Participate in cross-functional process initiatives. Perform clinical data management activities including developing of Data Transfer requirements and DMP (Data Management Plan), reviewing and processing clinical trial data to ensure data quality for data analysis and database lock. Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by NIAID (National Institute of Allergy & Infectious Diseases), or as necessary, clinical study related information from databases used by other Branches or Offices in NIAID. REQUIREMENTS: The contractor must have: Master's degree in a related discipline; three (3) years of specialized experience plus a Bachelor's degree is equivalent to a Master's degree. Minimum of three (3) years of related clinical data experience. At least five (5) years of clinical data management experience is required. Working knowledge of clinical data management tools. Experience programming and using Medidata Rave desired. Systems validation expertise and/or experience. Knowledge of data systems architecture and structure of data systems. Pharmaceutical industry experience a plus. Expertise in Microsoft Office Suite (MS Word, Excel, Outlook). Excellent analytical, organizational and time management skills. PLEASE APPLY ONLINE Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted. Why Kelly ® ? Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you. About Kelly ® Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We're always thinking about what's next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.
01/15/2021
Full time
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Senior Clinical Data Manager, with demonstrated experience in clinical trials, to work onsite with the National Institutes of Health in Rockville, MD. This is a long-term contract position which offers: - Competitive salary with comprehensive benefit package - Opportunity to work at NIH, the world's foremost medical research center - Learn more about what Kelly can do for you at TASKS: The contractor shall: Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs. Provide technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures. Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs. Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing. Conducts data reviews. Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards. Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing) Participate in cross-functional process initiatives. Perform clinical data management activities including developing of Data Transfer requirements and DMP (Data Management Plan), reviewing and processing clinical trial data to ensure data quality for data analysis and database lock. Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by NIAID (National Institute of Allergy & Infectious Diseases), or as necessary, clinical study related information from databases used by other Branches or Offices in NIAID. REQUIREMENTS: The contractor must have: Master's degree in a related discipline; three (3) years of specialized experience plus a Bachelor's degree is equivalent to a Master's degree. Minimum of three (3) years of related clinical data experience. At least five (5) years of clinical data management experience is required. Working knowledge of clinical data management tools. Experience programming and using Medidata Rave desired. Systems validation expertise and/or experience. Knowledge of data systems architecture and structure of data systems. Pharmaceutical industry experience a plus. Expertise in Microsoft Office Suite (MS Word, Excel, Outlook). Excellent analytical, organizational and time management skills. PLEASE APPLY ONLINE Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted. Why Kelly ® ? Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you. About Kelly ® Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We're always thinking about what's next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. Position Summary Pulse Biosciences is seeking a Senior Manager of Clinical Trials to join our dynamic team in our Hayward office. This exceptional leader will be responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to Pulse Biosciences internal management. These activities may include but are not limited to managing projects with activities focused on clinical operations, data management, statistics, medical writing, subject randomization and study device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies. Essential Duties and Responsibilities Manage projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies. Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines. Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH/GCP guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. Ensure the timely initiation and completion of clinical study projects. Recruit, hire and maintain a high performing Clinical team to drive and achieve Company goals. Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals. Manage activities between Pulse Biosciences and study sites, and with various supporting groups or thirdparty vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met. Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities. Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations. Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders. Function as meeting facilitator for the meetings involving various internal and external participants. Function as facilitator of problem solving and conflict resolution. Communicate project action items and key decisions through timely minutes and follow up actions. Conduct "lessons learned" meetings with project team members to learn from failures and prevent same from future projects. Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects. This position may assist the organization in responding to and preparing for Request for Information and Request for Proposals for Investigator Initiated Studies, and subsequently defining work scopes and budgets, and performing contract administration activities. When required, this position may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure Education and Experience Minimum BS / BA (science or healthcare field) or equivalent experience. Minimum of 8 years' clinical research experience within a medical device, or biotechnology setting. Minimum of 5 years' project management experience is required. Proven management of overseeing a minimum of 3 Clinical Research Associates for at least 5 years' is preferred. Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks. Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and device supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing. Knowledge and understanding of ICH/GCP guidelines, FDA, Health Canada, and EMA regulations. Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines. Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets. Skills, Abilities, and Other Requirements Proficient knowledge and skill in Microsoft Office Suite applications. Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills. Strong ability in problem-solving including conflict resolution. Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction. Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company. Ability to travel up 35% of the time. Overnight and/or international travel may be required. Ability to lift 10-15 pounds. Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at . At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities. Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals. Legal
01/15/2021
Full time
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. Position Summary Pulse Biosciences is seeking a Senior Manager of Clinical Trials to join our dynamic team in our Hayward office. This exceptional leader will be responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to Pulse Biosciences internal management. These activities may include but are not limited to managing projects with activities focused on clinical operations, data management, statistics, medical writing, subject randomization and study device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies. Essential Duties and Responsibilities Manage projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies. Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines. Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH/GCP guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. Ensure the timely initiation and completion of clinical study projects. Recruit, hire and maintain a high performing Clinical team to drive and achieve Company goals. Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals. Manage activities between Pulse Biosciences and study sites, and with various supporting groups or thirdparty vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met. Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities. Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations. Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders. Function as meeting facilitator for the meetings involving various internal and external participants. Function as facilitator of problem solving and conflict resolution. Communicate project action items and key decisions through timely minutes and follow up actions. Conduct "lessons learned" meetings with project team members to learn from failures and prevent same from future projects. Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects. This position may assist the organization in responding to and preparing for Request for Information and Request for Proposals for Investigator Initiated Studies, and subsequently defining work scopes and budgets, and performing contract administration activities. When required, this position may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure Education and Experience Minimum BS / BA (science or healthcare field) or equivalent experience. Minimum of 8 years' clinical research experience within a medical device, or biotechnology setting. Minimum of 5 years' project management experience is required. Proven management of overseeing a minimum of 3 Clinical Research Associates for at least 5 years' is preferred. Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks. Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and device supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing. Knowledge and understanding of ICH/GCP guidelines, FDA, Health Canada, and EMA regulations. Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines. Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets. Skills, Abilities, and Other Requirements Proficient knowledge and skill in Microsoft Office Suite applications. Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills. Strong ability in problem-solving including conflict resolution. Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction. Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company. Ability to travel up 35% of the time. Overnight and/or international travel may be required. Ability to lift 10-15 pounds. Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at . At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities. Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals. Legal
Description Senior Contract Specialist - Research Administration - Orlando Location Address: 800 N. Magnolia Ave., Orlando, FL 32801 Top Reasons to work at AdventHealth Orlando Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando serves as the major tertiary facility for much of the Southeast, the Caribbean and South America AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year Work Hours/Shift: Full Time, Days You Will Be Responsible For: The Senior Contract Specialist will play a vital role in support of research under the auspices of AdventHealth. The Senior Contract Specialist exercises objective and independent judgement in interpreting regulations and contract language, negotiating terms and conditions, managing contract compliance, and in making recommendations to departments and leadership The Senior Contract Specialist is knowledgeable in the area of clinical trial agreement contract negotiation, terms and conditions. The Senior Contract Specialist will be responsible for the review, negotiation, tracking, finalization and administrative management of contracts and agreements to support the mission of AdventHealth Research Institute. The Senior Contract Specialist actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all. Qualifications What You Will Need: Required: Bachelor's degree in legal studies, healthcare, business administration, finance, accounting, or research-related field OR paralegal certification Three (3) years' experience in reviewing, writing, editing, and negotiating contracts preferably in an academic or medical setting Experience in research or contract administration Proficient knowledge and understanding of clinical trial agreements and other grant and contract funding mechanisms, including related policies and procedures, and contract management. Proficient knowledge and understanding of research related clinical trial and other related contract terms (e.g. human subjects, animal, confidentiality, biohazard, export control, intellectual property, etc.) Proficient knowledge of related federal and state regulations, e.g. Food and Drug Administration (FDA), Department Health and Human Services (DHHS), Code of Federal Regulations (CFRs), Office of Management and Budget (OMB), as they relation to research administration Proficient knowledge of research compliance requirements (e.g. human subjects, animal, biohazard, export control, intellectual property, etc.) Excellent interpersonal skills and a collaborative style necessary for interaction across departments. Motivated, organized and able to function independently Advanced written and verbal communication skills with demonstrated proficiency for current spelling, grammar, tone, and syntax Proficient in MS Office Suite (Outlook, Word, Excel, Publisher, PowerPoint, etc), internet, and other research tools, word-processing and databases Preferred: Over three (3) years of reviewing, writing, editing, and negotiating contracts preferably in an academic or medical setting Experience in grant and/or clinical trial agreement administration and management in a research or medical setting. Certification by a professional research organization such as Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators (SRA), Research Administrator's Certification Council (RACC), or Health Care Compliance Association (HCCA) Certification by a paralegal professional organization such as The National Federation of Paralegal Associations (NFPA), The National Association of Legal Assistants (NALA), or The Association for Legal Professionals (NALS) Job Summary: Orients, trains, and mentors new staff as well as contract specialists in areas related to contract drafting and negotiation. In coordination with the Manager Sponsored programs, Clinical Trial Agreements & Contracts manages efforts and workflow to achieve department goals and objectives, such as decreased activation times. Creates, reviews, revises, and negotiates simple and complex research-related contracts, including amendments, consistent with relevant clinical trials study documents (e.g. protocol, informed consent, budget, manuals, etc.), institutional policies and procedures, and applicable federal, state, and local regulations. Exercises independent judgement to provides guidance and interpretation of contract terms, federal, state, and local laws, and institutional policies and procedures internally and externally to resolve issues and to ensure compliance. Follows, develops, and updates established processes pre and post-execution to ensure metrics and tracking, compliance, document harmonization, and timely execution of contracts. Consults with stakeholders and partners to solve simple and complex problems related to research studies and applying knowledge of applicable regulations, institutional policies and procedures, and logistics and programmatic requirements of conducting research. Facilitates the execution of clinical trial agreements and/or related requests. Serves as a liaison with the Institutes, Research Operations and AdventHealth Legal department to ensure clinical trial and other agreements are processed timely. Interacts directly with all levels of management and staff to provide useful information, guidance, and integrity to contract negotiation, execution, and compliance. Assists in developing, enhancing, and communicating policies and procedures in research administration. Manages and/or assists with special projects in research administration processes, as assigned. This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
01/13/2021
Full time
Description Senior Contract Specialist - Research Administration - Orlando Location Address: 800 N. Magnolia Ave., Orlando, FL 32801 Top Reasons to work at AdventHealth Orlando Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando serves as the major tertiary facility for much of the Southeast, the Caribbean and South America AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year Work Hours/Shift: Full Time, Days You Will Be Responsible For: The Senior Contract Specialist will play a vital role in support of research under the auspices of AdventHealth. The Senior Contract Specialist exercises objective and independent judgement in interpreting regulations and contract language, negotiating terms and conditions, managing contract compliance, and in making recommendations to departments and leadership The Senior Contract Specialist is knowledgeable in the area of clinical trial agreement contract negotiation, terms and conditions. The Senior Contract Specialist will be responsible for the review, negotiation, tracking, finalization and administrative management of contracts and agreements to support the mission of AdventHealth Research Institute. The Senior Contract Specialist actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all. Qualifications What You Will Need: Required: Bachelor's degree in legal studies, healthcare, business administration, finance, accounting, or research-related field OR paralegal certification Three (3) years' experience in reviewing, writing, editing, and negotiating contracts preferably in an academic or medical setting Experience in research or contract administration Proficient knowledge and understanding of clinical trial agreements and other grant and contract funding mechanisms, including related policies and procedures, and contract management. Proficient knowledge and understanding of research related clinical trial and other related contract terms (e.g. human subjects, animal, confidentiality, biohazard, export control, intellectual property, etc.) Proficient knowledge of related federal and state regulations, e.g. Food and Drug Administration (FDA), Department Health and Human Services (DHHS), Code of Federal Regulations (CFRs), Office of Management and Budget (OMB), as they relation to research administration Proficient knowledge of research compliance requirements (e.g. human subjects, animal, biohazard, export control, intellectual property, etc.) Excellent interpersonal skills and a collaborative style necessary for interaction across departments. Motivated, organized and able to function independently Advanced written and verbal communication skills with demonstrated proficiency for current spelling, grammar, tone, and syntax Proficient in MS Office Suite (Outlook, Word, Excel, Publisher, PowerPoint, etc), internet, and other research tools, word-processing and databases Preferred: Over three (3) years of reviewing, writing, editing, and negotiating contracts preferably in an academic or medical setting Experience in grant and/or clinical trial agreement administration and management in a research or medical setting. Certification by a professional research organization such as Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators (SRA), Research Administrator's Certification Council (RACC), or Health Care Compliance Association (HCCA) Certification by a paralegal professional organization such as The National Federation of Paralegal Associations (NFPA), The National Association of Legal Assistants (NALA), or The Association for Legal Professionals (NALS) Job Summary: Orients, trains, and mentors new staff as well as contract specialists in areas related to contract drafting and negotiation. In coordination with the Manager Sponsored programs, Clinical Trial Agreements & Contracts manages efforts and workflow to achieve department goals and objectives, such as decreased activation times. Creates, reviews, revises, and negotiates simple and complex research-related contracts, including amendments, consistent with relevant clinical trials study documents (e.g. protocol, informed consent, budget, manuals, etc.), institutional policies and procedures, and applicable federal, state, and local regulations. Exercises independent judgement to provides guidance and interpretation of contract terms, federal, state, and local laws, and institutional policies and procedures internally and externally to resolve issues and to ensure compliance. Follows, develops, and updates established processes pre and post-execution to ensure metrics and tracking, compliance, document harmonization, and timely execution of contracts. Consults with stakeholders and partners to solve simple and complex problems related to research studies and applying knowledge of applicable regulations, institutional policies and procedures, and logistics and programmatic requirements of conducting research. Facilitates the execution of clinical trial agreements and/or related requests. Serves as a liaison with the Institutes, Research Operations and AdventHealth Legal department to ensure clinical trial and other agreements are processed timely. Interacts directly with all levels of management and staff to provide useful information, guidance, and integrity to contract negotiation, execution, and compliance. Assists in developing, enhancing, and communicating policies and procedures in research administration. Manages and/or assists with special projects in research administration processes, as assigned. This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health , the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu , and interact with us on LinkedIn , Glassdoor , Indeed , Facebook , Twitter and Instagram . Position Summary: We have an exciting opportunity to join our team as a Sr. Contract Specialist. The Sr. Contract Specialist is responsible for the review and negotiation of contracts, grant agreements and other agreements (including subawards and service agreements) administered by SPA. The position entails processing of all contracts and liaising with sponsoring agencies, collaborating institutions, the Deans Office, the Principal Investigator (PI) and the PIs department, Office of Science and Research units such as Industrial Liaison (OIL), Clinical Trials (OCT), as well as other central administration departments such as the Development Office, the Office of Legal Counsel (OLC), the Department of Insurance & Enterprise Risk Management (Insurance) and others. The Sr. Contracts Specialist must work as part of a team with the research community to prepare contracts, grant agreements and other agreements for proper execution. Job Responsibilities: Performs other administrative duties as assigned by supervisor. Participates in activities related to systems improvement within SPA. Performs copying, scanning, distribution and filing of all contractual documentation relating to any research projects being processed through SPA. Performs general word processing duties utilizing intermediate to advanced-level functions. Demonstrates knowledge of the NYUSoMs service standards and incorporates them into the performance of duties. Assists supervisor in development of new forms, guidelines, manuals and directions in connection with SPA contracting process; suggests changes to SPA processes to increase efficiency or clarity or otherwise improve them. Alerts supervisor to any significant changes in documents requiring managerial review. Alerts supervisors to any significant changes in documents, requiring managerial review. Maintains current knowledge of all relevant procedures, forms, guidelines, manuals, directives, laws, etc., that apply to the contracting process at NYUSoM. Modifies and/or creates databases and complex spreadsheets. Customizes and/or composes letters on own initiative or in response to requests for information; actively educates departments and PIs as appropriate to ensure expeditious use of SPA systems. Assists, under the direction of the Director of SPA, with prioritizing SPA office activities (e.g., respond to inquiries using comprehensive knowledge of SPAs activities, policies and procedures). Assists with monitoring budget; alerts supervisor of discrepancies and resolves within guidelines; assists with preparing related reports as requested. Updates other departments and stakeholders of statuses and maintains such information within an accessible system for all contracts, grant agreements and other agreements in accordance with SPA procedures; manages delays by coordinating with departments as PI as appropriate. Obtains all required internal supporting documents for each agreement, including insurance, indemnification, compliance and internal approval documentation as required per the agreement and internal policy. Using knowledge of various processes of other departments, SPA guidelines, advice sought from supervisors, liaises with Principal Investigators, research coordinators, OSR, OIL, OCT and Development to resolve contract and contract-related issues (such as invoicing issues, study start-up delays, requests related to audits). Ensures timely processing of contracts and other award agreements for proper signature as well as all other aspects of agreement execution (e.g., coordinating with sponsoring agencies, collaborating institutions, PIs and departments to obtain the appropriate final documents, coordinate with investigators to make sure all appropriate signatures are obtained, and compile the agreement and all other contractual documentation for signature). Identifies and implements useful precedents for the agreement based on patterns established by previously reviewed contracts. Crafts persuasive arguments to influence external sponsors and collaborating institutions during negotiations. Drafts agreements leveraging existing templates based on circumstances of specific matters, using a familiarity with the templates, interaction with department, knowledge of existing laws and regulations to ensure that the NYUSoMs and the PIs interests are properly protected. Acts as principal liaison on agreement review, negotiation and processing between SPA and sponsoring agencies (including government, foundation and industry sponsors), collaborating institutions, PIs, OSR, OIL, OCT, Development, OLC, Insurance, Research Finance and other departments or offices and individuals involved in SPAs contract review and negotiation, all in accordance with SPAs guidelines and supervisor instruction; incorporates and reconciles conflicting advice, proposes appropriate solutions and harmonizes processes between conflicting departments when necessary. Provides legal review of, negotiates and processes industry-sponsored clinical trial agreements, foundation and government grants and contracts, peer institution memorandums and related agreements (e.g., marking up agreements based on templates, guidelines and training; and seeking advice and direction from SPA supervisor, OLC, and Insurance for situations independently identified as outside the scope of training or presenting risk to the institution) within prescribed timelines. Minimum Qualifications: To qualify you must have a Bachelors degree plus five or more years of related experience in research or contracts or a Juris Doctorate with one year of experience in research or contracts. Excellent interpersonal, written and verbal communication skills. Understanding of common legal concepts and contractual terms. Ability to manage competing priorities and tight deadlines. Ability to work and make decisions independently. Ability to execute faithfully institutional guidelines and directions. Ability to work effectively with various stakeholders through listening and creative synthesis of conflicting positions to develop solutions. Ability to summarize legal issues concisely. Ability to use PC for analysis and correspondence. Proofreading and typing skills. Preferred Qualifications: Background involving two years of review and negotiation of academic or medical grants and contracts strongly preferred. Juris Doctorate or Masters degree preferred. Familiarity with relevant federal regulations and laws preferred. Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here . Please click here to view the Federal "EEO is the law" poster or visit for more information. To view the Pay Transparency Notice, please click here .
10/02/2020
Full time
NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health , the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu , and interact with us on LinkedIn , Glassdoor , Indeed , Facebook , Twitter and Instagram . Position Summary: We have an exciting opportunity to join our team as a Sr. Contract Specialist. The Sr. Contract Specialist is responsible for the review and negotiation of contracts, grant agreements and other agreements (including subawards and service agreements) administered by SPA. The position entails processing of all contracts and liaising with sponsoring agencies, collaborating institutions, the Deans Office, the Principal Investigator (PI) and the PIs department, Office of Science and Research units such as Industrial Liaison (OIL), Clinical Trials (OCT), as well as other central administration departments such as the Development Office, the Office of Legal Counsel (OLC), the Department of Insurance & Enterprise Risk Management (Insurance) and others. The Sr. Contracts Specialist must work as part of a team with the research community to prepare contracts, grant agreements and other agreements for proper execution. Job Responsibilities: Performs other administrative duties as assigned by supervisor. Participates in activities related to systems improvement within SPA. Performs copying, scanning, distribution and filing of all contractual documentation relating to any research projects being processed through SPA. Performs general word processing duties utilizing intermediate to advanced-level functions. Demonstrates knowledge of the NYUSoMs service standards and incorporates them into the performance of duties. Assists supervisor in development of new forms, guidelines, manuals and directions in connection with SPA contracting process; suggests changes to SPA processes to increase efficiency or clarity or otherwise improve them. Alerts supervisor to any significant changes in documents requiring managerial review. Alerts supervisors to any significant changes in documents, requiring managerial review. Maintains current knowledge of all relevant procedures, forms, guidelines, manuals, directives, laws, etc., that apply to the contracting process at NYUSoM. Modifies and/or creates databases and complex spreadsheets. Customizes and/or composes letters on own initiative or in response to requests for information; actively educates departments and PIs as appropriate to ensure expeditious use of SPA systems. Assists, under the direction of the Director of SPA, with prioritizing SPA office activities (e.g., respond to inquiries using comprehensive knowledge of SPAs activities, policies and procedures). Assists with monitoring budget; alerts supervisor of discrepancies and resolves within guidelines; assists with preparing related reports as requested. Updates other departments and stakeholders of statuses and maintains such information within an accessible system for all contracts, grant agreements and other agreements in accordance with SPA procedures; manages delays by coordinating with departments as PI as appropriate. Obtains all required internal supporting documents for each agreement, including insurance, indemnification, compliance and internal approval documentation as required per the agreement and internal policy. Using knowledge of various processes of other departments, SPA guidelines, advice sought from supervisors, liaises with Principal Investigators, research coordinators, OSR, OIL, OCT and Development to resolve contract and contract-related issues (such as invoicing issues, study start-up delays, requests related to audits). Ensures timely processing of contracts and other award agreements for proper signature as well as all other aspects of agreement execution (e.g., coordinating with sponsoring agencies, collaborating institutions, PIs and departments to obtain the appropriate final documents, coordinate with investigators to make sure all appropriate signatures are obtained, and compile the agreement and all other contractual documentation for signature). Identifies and implements useful precedents for the agreement based on patterns established by previously reviewed contracts. Crafts persuasive arguments to influence external sponsors and collaborating institutions during negotiations. Drafts agreements leveraging existing templates based on circumstances of specific matters, using a familiarity with the templates, interaction with department, knowledge of existing laws and regulations to ensure that the NYUSoMs and the PIs interests are properly protected. Acts as principal liaison on agreement review, negotiation and processing between SPA and sponsoring agencies (including government, foundation and industry sponsors), collaborating institutions, PIs, OSR, OIL, OCT, Development, OLC, Insurance, Research Finance and other departments or offices and individuals involved in SPAs contract review and negotiation, all in accordance with SPAs guidelines and supervisor instruction; incorporates and reconciles conflicting advice, proposes appropriate solutions and harmonizes processes between conflicting departments when necessary. Provides legal review of, negotiates and processes industry-sponsored clinical trial agreements, foundation and government grants and contracts, peer institution memorandums and related agreements (e.g., marking up agreements based on templates, guidelines and training; and seeking advice and direction from SPA supervisor, OLC, and Insurance for situations independently identified as outside the scope of training or presenting risk to the institution) within prescribed timelines. Minimum Qualifications: To qualify you must have a Bachelors degree plus five or more years of related experience in research or contracts or a Juris Doctorate with one year of experience in research or contracts. Excellent interpersonal, written and verbal communication skills. Understanding of common legal concepts and contractual terms. Ability to manage competing priorities and tight deadlines. Ability to work and make decisions independently. Ability to execute faithfully institutional guidelines and directions. Ability to work effectively with various stakeholders through listening and creative synthesis of conflicting positions to develop solutions. Ability to summarize legal issues concisely. Ability to use PC for analysis and correspondence. Proofreading and typing skills. Preferred Qualifications: Background involving two years of review and negotiation of academic or medical grants and contracts strongly preferred. Juris Doctorate or Masters degree preferred. Familiarity with relevant federal regulations and laws preferred. Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here . Please click here to view the Federal "EEO is the law" poster or visit for more information. To view the Pay Transparency Notice, please click here .
Description: Our client is looking for a Senior Biostatistician for their NNJ offices. The right candidate will: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as Lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. Thanks and Regards, Ali Sarwar ARAXIS SYSTEMS INC. Email ID: - provided by Dice
10/02/2020
Full time
Description: Our client is looking for a Senior Biostatistician for their NNJ offices. The right candidate will: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as Lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. Thanks and Regards, Ali Sarwar ARAXIS SYSTEMS INC. Email ID: - provided by Dice