Job Description The Director, Business Development, Global Commercial Development will report to the Director, Pipeline Commercialization & Strategy, Oncology. This person will play an integral driving role in the sourcing and evaluation of new investment opportunities through the leadership and management of commercial assessments related to the TA strategy and due diligence. This individual will also play an integral driving role in the Therapeutic Area's business development process internally and externally with other biopharmaceutical companies targeting licensing/acquisition of key therapeutic assets, R&D collaborations, and related enabling collaborations. The successful candidate will have a strong scientific, commercial, and/or clinical background and be able to understand business principles and market dynamics across various disease areas and indications within the Oncology Solid Tumors and Hematology sectors. Specific activities will include working with the Search & Evaluation and BD&A Transactions teams to support execution of the BD strategy, plan & prepare commercial diligence presentations, guiding product forecasting and P&L generation and work with the Business Insights Team to perform market insights generation and gather secondary analytics. The position provides the opportunity to work with a variety of key stakeholders, including but not limited to: Search and Evaluation, Licensing & Acquisition, Clinical, Discovery, Regulatory, Market Access, Health Economics, US & Global Commercial, Forecasting, Finance, and Market Research partners. Due to the cross-portfolio nature of the role, the candidate will also be involved in the preparation of other strategic initiatives, including contributions for BD strategy into the Long-Range Planning process and input into Disease Area Strategies. Key Responsibilities Include: Work with internal research, development, search and evaluation, commercial and financial analytics experts on the evaluation, due diligence, and initial product development plan for proposed transactions. This includes supporting the overall product evaluation process, including clinical / scientific assessments, evaluation of the commercial opportunity, analysis of the competitive landscape, and financial modeling Serve as commercial lead for internal due diligence process with Clinical, Commercial, Regulatory, Finance, Legal & IP, and Manufacturing, to conduct detailed evaluation process Lead commercial due diligence of external assets and ensure that tight timelines are on track Partner with the Commercial Disease Area and Clinical teams to generate product profiles for external asset evaluations Work with the Business Insights team to perform any needed market assessments Provide input on clinical development plans for external asset evaluations Guide the forecasting team in external asset sales modeling Partner with Business Development commercial teams in P&L generation, including operating expense assumptions Frame up strategic and financial benefits of deals under evaluation Generate and present clear and concise commercial diligence decks to Senior Leadership Attend scientific and medical conferences to stay abreast of new developments in key therapeutic areas
04/24/2024
Full time
Job Description The Director, Business Development, Global Commercial Development will report to the Director, Pipeline Commercialization & Strategy, Oncology. This person will play an integral driving role in the sourcing and evaluation of new investment opportunities through the leadership and management of commercial assessments related to the TA strategy and due diligence. This individual will also play an integral driving role in the Therapeutic Area's business development process internally and externally with other biopharmaceutical companies targeting licensing/acquisition of key therapeutic assets, R&D collaborations, and related enabling collaborations. The successful candidate will have a strong scientific, commercial, and/or clinical background and be able to understand business principles and market dynamics across various disease areas and indications within the Oncology Solid Tumors and Hematology sectors. Specific activities will include working with the Search & Evaluation and BD&A Transactions teams to support execution of the BD strategy, plan & prepare commercial diligence presentations, guiding product forecasting and P&L generation and work with the Business Insights Team to perform market insights generation and gather secondary analytics. The position provides the opportunity to work with a variety of key stakeholders, including but not limited to: Search and Evaluation, Licensing & Acquisition, Clinical, Discovery, Regulatory, Market Access, Health Economics, US & Global Commercial, Forecasting, Finance, and Market Research partners. Due to the cross-portfolio nature of the role, the candidate will also be involved in the preparation of other strategic initiatives, including contributions for BD strategy into the Long-Range Planning process and input into Disease Area Strategies. Key Responsibilities Include: Work with internal research, development, search and evaluation, commercial and financial analytics experts on the evaluation, due diligence, and initial product development plan for proposed transactions. This includes supporting the overall product evaluation process, including clinical / scientific assessments, evaluation of the commercial opportunity, analysis of the competitive landscape, and financial modeling Serve as commercial lead for internal due diligence process with Clinical, Commercial, Regulatory, Finance, Legal & IP, and Manufacturing, to conduct detailed evaluation process Lead commercial due diligence of external assets and ensure that tight timelines are on track Partner with the Commercial Disease Area and Clinical teams to generate product profiles for external asset evaluations Work with the Business Insights team to perform any needed market assessments Provide input on clinical development plans for external asset evaluations Guide the forecasting team in external asset sales modeling Partner with Business Development commercial teams in P&L generation, including operating expense assumptions Frame up strategic and financial benefits of deals under evaluation Generate and present clear and concise commercial diligence decks to Senior Leadership Attend scientific and medical conferences to stay abreast of new developments in key therapeutic areas
St. Jude Children's Research Hospital
Memphis, Tennessee
St. Jude Children's Research Hospital St Jude Children's Research Hospita l is a private, not-for-profit institute that is internationally recognized for its commitment to providing state of the art clinical services, while performing innovative scientific and patient-directed research. St. Jude is the first and only pediatric cancer center to be designated as a Comprehensive Cancer Center by the National Cancer Institute. We seek a highly motivated, faculty-level (clinician scientist track) at the Associate or Full Member level with training in hematology-oncology, a proven track of leadership capacity, and a strong interest in clinical/translational research and clinical care activities. The preferred candidate should also have experience in mentorship and fellowship training within the academic setting, and in incorporating quality and/or process improvement into daily inpatient/outpatient clinical practice. The Department of Oncology is comprised of multiple Divisions inclusive of Leukemia-Lymphoma, Neuro-oncology, Solid Tumor, Palliative Care & Quality of Life, Cancer Predisposition, Cancer Survivorship, and Molecular Oncology. The Department is also closely aligned with the St. Jude NCI-funded Comprehensive Cancer Center with each Oncology Division providing the opportunity for translation of basic and translation research. This position will report directly to the Chair of the Department of Oncology, lead divisional clinical research, and oversee Leukemia-Lymphoma patient care services in collaboration with the Director of Oncology Clinical Medicine and the Chair. The Department of Oncology provides a highly collaborative and interactive environment where faculty members have ample opportunities to participate in clinical, educational, and translational research initiatives. As an integral member of the leadership team of the department, the Division Director of Leukemia-Lymphoma ensures alignment of divisional goals with institutional and departmental strategic goals and initiatives, oversees divisional faculty development, and promotes outstanding multidisciplinary care delivery and research activities. This position will also play an essential role in implementing strategies incorporating clinical education into daily practice to ensure the satisfactory learning experience of Hem-Onc fellows, residents, and medical school students in Leukemia-Lymphoma service. This is a remarkable opportunity to be part of a positive workplace where all employees, regardless of their role, share the same commitment to make a difference in the lives of children with cancer and other catastrophic illnesses. St. Jude is consistently ranked on Fortune Magazine's "100 Best Places to Work For" and listed on Glassdoor 100 Best Places to Work for the last 6 years for companies with 1,000 or more employees. This position is based in Memphis, TN with relocation assistance available. The facilities and salaries are competitive, and a generous benefit package is included. Memphis is a family-friendly metropolitan area that is recognized for its world-class music, food, and hospitality. Mild winters and beautiful green spaces are part of the reasons why Forbes recently named Memphis the 4th happiest city in which to work. It is essential that candidates have an MD, MD/PhD or DO degree and be Board certified or Board-eligible in pediatric hematology-oncology. Successful candidates will have expertise in the areas of hematology and oncology, as the faculty member will be involved in clinical care. A letter of inquiry and CV should be submitted directly online. Alternatively, the letter of inquiry and CV can be sent to: Julie Park, MD St. Jude Children's Research Hospital 262 Danny Thomas Place Mailstop 260 Memphis TN Email: Diversity, Equity and Inclusion St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment . Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future. St. Jude is an Equal Opportunity Employer No Search Firms St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
04/20/2024
Full time
St. Jude Children's Research Hospital St Jude Children's Research Hospita l is a private, not-for-profit institute that is internationally recognized for its commitment to providing state of the art clinical services, while performing innovative scientific and patient-directed research. St. Jude is the first and only pediatric cancer center to be designated as a Comprehensive Cancer Center by the National Cancer Institute. We seek a highly motivated, faculty-level (clinician scientist track) at the Associate or Full Member level with training in hematology-oncology, a proven track of leadership capacity, and a strong interest in clinical/translational research and clinical care activities. The preferred candidate should also have experience in mentorship and fellowship training within the academic setting, and in incorporating quality and/or process improvement into daily inpatient/outpatient clinical practice. The Department of Oncology is comprised of multiple Divisions inclusive of Leukemia-Lymphoma, Neuro-oncology, Solid Tumor, Palliative Care & Quality of Life, Cancer Predisposition, Cancer Survivorship, and Molecular Oncology. The Department is also closely aligned with the St. Jude NCI-funded Comprehensive Cancer Center with each Oncology Division providing the opportunity for translation of basic and translation research. This position will report directly to the Chair of the Department of Oncology, lead divisional clinical research, and oversee Leukemia-Lymphoma patient care services in collaboration with the Director of Oncology Clinical Medicine and the Chair. The Department of Oncology provides a highly collaborative and interactive environment where faculty members have ample opportunities to participate in clinical, educational, and translational research initiatives. As an integral member of the leadership team of the department, the Division Director of Leukemia-Lymphoma ensures alignment of divisional goals with institutional and departmental strategic goals and initiatives, oversees divisional faculty development, and promotes outstanding multidisciplinary care delivery and research activities. This position will also play an essential role in implementing strategies incorporating clinical education into daily practice to ensure the satisfactory learning experience of Hem-Onc fellows, residents, and medical school students in Leukemia-Lymphoma service. This is a remarkable opportunity to be part of a positive workplace where all employees, regardless of their role, share the same commitment to make a difference in the lives of children with cancer and other catastrophic illnesses. St. Jude is consistently ranked on Fortune Magazine's "100 Best Places to Work For" and listed on Glassdoor 100 Best Places to Work for the last 6 years for companies with 1,000 or more employees. This position is based in Memphis, TN with relocation assistance available. The facilities and salaries are competitive, and a generous benefit package is included. Memphis is a family-friendly metropolitan area that is recognized for its world-class music, food, and hospitality. Mild winters and beautiful green spaces are part of the reasons why Forbes recently named Memphis the 4th happiest city in which to work. It is essential that candidates have an MD, MD/PhD or DO degree and be Board certified or Board-eligible in pediatric hematology-oncology. Successful candidates will have expertise in the areas of hematology and oncology, as the faculty member will be involved in clinical care. A letter of inquiry and CV should be submitted directly online. Alternatively, the letter of inquiry and CV can be sent to: Julie Park, MD St. Jude Children's Research Hospital 262 Danny Thomas Place Mailstop 260 Memphis TN Email: Diversity, Equity and Inclusion St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment . Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future. St. Jude is an Equal Opportunity Employer No Search Firms St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.
Job Description Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Ensures that staff provides project-related education of investigators, study site personnel, and AbbVie study staff. Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches. Ensures that staff have capabilities to monitor overall study integrity, study enrollment and timelines. Provides or ensures clarity regarding the appropriate level for review and approval of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Manages two levels of Medical and Scientific Directors (typically 2 to 4 direct; 6 or more overall) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals. In rare circumstances, may lead a CST for an unusually complex, high-priority program. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs, and/or other cross-functional teams and internal stakeholders. Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level. Acts as a senior-level liaison for opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into disease area strategies and Clinical Development Plans as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Actively seeks opportunities to represent AbbVie at key external meetings and enhance AbbVie's reputation as an industry leader. Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
04/17/2024
Full time
Job Description Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Ensures that staff provides project-related education of investigators, study site personnel, and AbbVie study staff. Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches. Ensures that staff have capabilities to monitor overall study integrity, study enrollment and timelines. Provides or ensures clarity regarding the appropriate level for review and approval of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Manages two levels of Medical and Scientific Directors (typically 2 to 4 direct; 6 or more overall) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals. In rare circumstances, may lead a CST for an unusually complex, high-priority program. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs, and/or other cross-functional teams and internal stakeholders. Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level. Acts as a senior-level liaison for opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into disease area strategies and Clinical Development Plans as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Actively seeks opportunities to represent AbbVie at key external meetings and enhance AbbVie's reputation as an industry leader. Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Unlock your potential for professional development! We are hiring a full time Clinical Trials Oncology RN to join Our Cancer Center! This position is onsite! Located in northwest Arizona, Kingman has a mild climate with stunning Arizona sunsets! In the shadows of beautiful mountain ranges and nearby lakes, Kingman is an outdoor enthusiasts' paradise with abundant sunshine and is a great community to live, work and play! Benefits ( Full Time Employees ) We offer you an excellent total compensation package, including a competitive salary, comprehensive benefits, and growth opportunities: Exceptional Colleagues Join us and you'll be a part of a culture where we support each other and celebrate what makes each of us a special person as we work together with integrity, compassion, teamwork, respect, and accountability. Our leaders demonstrate their commitment by gathering feedback, supporting, and empowering team members to do their best work through regular leadership rounding. Health and Well-Being Medical, Dental, Vision, Employer Paid HSA for HDHP participants, Robust Wellness and Employee Assistance Program, Employer Paid Group Life, Short & Long-Term Disability Generous Paid Leave Accruals 403b Retirement Plan with Employer Contributions Employee Recognition Programs, Employee Discounts, and Employee Referral Bonus Program Employee Identity Theft Protection On-site daycare exclusive to our employees children of all ages Employer Paid Employee Wellness Center Membership with fitness classes, personal training, indoor pool, racquetball, and basketball courts Career Growth and Development Tuition Reimbursement/Scholarships for full-time employees As a not-for-profit organization, our employees who have qualified student loans may be eligible for the Public Service Loan Forgiveness program So much more! Position Purpose All KHI employees are expected to perform their respective tasks and duties in such a way that supports KHI s vision to be among the kindest, highest quality health systems in the country. The Clinical Research Administrator will design, coordinate, and oversee research projects and the clinical trials program within the Cancer Center department. Key Responsibilities • Works with director and medical director to formulate the oncology clinical trials accrual plan. • Adheres to the oncology clinical trials accrual plan. • Recruits and enrolls study participants. • Opens and closes clinical trials at the study site with the approval of the director, medical director and KHI IRB. • Inputs clinical research data into electronic data systems. • Coordinates patient visits and procedures related to research. • Acts as resource for study participants by answering questions and explaining related procedures. • Ensures the study site follows all local and federal laws and regulations. • Monitors study sites and activities to ensure the appropriate industry protocols and terms of the study are being followed. • Creates thorough documentation of study protocol and updates as needed. • Provides oversight to the research in the Cancer Center. • Provides analytic/statistical support as needed. • Ensures facility maintains adherence to the American College of Surgeon s Commission on Cancer s research standards. • Oversees accuracy and timeliness of billing charges related to clinical trials. • Ensures all staff have adequate training and certifications to treat patients in clinical trials Required Qualifications Experience: 2+ years of research experience or 5 years of clinical experience. Education: Bachelor s degree in nursing or bachelor s degree in a related field. Certification/Licensure: Certificate of Completion from Collaborative Institutional Training Initiative (CITI) Program within 6 months of hire. Knowledge, Skills and Abilities: • Must be proficient in basic computing software including but not limited to Microsoft Word, Excel, Power Point and Outlook. • Must possess the ability to write both scientifically and analytically. • Must be proficient in statistical analysis Preferred Qualifications • Master s Degree in nursing or research related field. • Certified Clinical Research Associate or Clinical Research Coordinator Credentials. • Principal Investigator Credentials.
04/13/2024
Full time
Unlock your potential for professional development! We are hiring a full time Clinical Trials Oncology RN to join Our Cancer Center! This position is onsite! Located in northwest Arizona, Kingman has a mild climate with stunning Arizona sunsets! In the shadows of beautiful mountain ranges and nearby lakes, Kingman is an outdoor enthusiasts' paradise with abundant sunshine and is a great community to live, work and play! Benefits ( Full Time Employees ) We offer you an excellent total compensation package, including a competitive salary, comprehensive benefits, and growth opportunities: Exceptional Colleagues Join us and you'll be a part of a culture where we support each other and celebrate what makes each of us a special person as we work together with integrity, compassion, teamwork, respect, and accountability. Our leaders demonstrate their commitment by gathering feedback, supporting, and empowering team members to do their best work through regular leadership rounding. Health and Well-Being Medical, Dental, Vision, Employer Paid HSA for HDHP participants, Robust Wellness and Employee Assistance Program, Employer Paid Group Life, Short & Long-Term Disability Generous Paid Leave Accruals 403b Retirement Plan with Employer Contributions Employee Recognition Programs, Employee Discounts, and Employee Referral Bonus Program Employee Identity Theft Protection On-site daycare exclusive to our employees children of all ages Employer Paid Employee Wellness Center Membership with fitness classes, personal training, indoor pool, racquetball, and basketball courts Career Growth and Development Tuition Reimbursement/Scholarships for full-time employees As a not-for-profit organization, our employees who have qualified student loans may be eligible for the Public Service Loan Forgiveness program So much more! Position Purpose All KHI employees are expected to perform their respective tasks and duties in such a way that supports KHI s vision to be among the kindest, highest quality health systems in the country. The Clinical Research Administrator will design, coordinate, and oversee research projects and the clinical trials program within the Cancer Center department. Key Responsibilities • Works with director and medical director to formulate the oncology clinical trials accrual plan. • Adheres to the oncology clinical trials accrual plan. • Recruits and enrolls study participants. • Opens and closes clinical trials at the study site with the approval of the director, medical director and KHI IRB. • Inputs clinical research data into electronic data systems. • Coordinates patient visits and procedures related to research. • Acts as resource for study participants by answering questions and explaining related procedures. • Ensures the study site follows all local and federal laws and regulations. • Monitors study sites and activities to ensure the appropriate industry protocols and terms of the study are being followed. • Creates thorough documentation of study protocol and updates as needed. • Provides oversight to the research in the Cancer Center. • Provides analytic/statistical support as needed. • Ensures facility maintains adherence to the American College of Surgeon s Commission on Cancer s research standards. • Oversees accuracy and timeliness of billing charges related to clinical trials. • Ensures all staff have adequate training and certifications to treat patients in clinical trials Required Qualifications Experience: 2+ years of research experience or 5 years of clinical experience. Education: Bachelor s degree in nursing or bachelor s degree in a related field. Certification/Licensure: Certificate of Completion from Collaborative Institutional Training Initiative (CITI) Program within 6 months of hire. Knowledge, Skills and Abilities: • Must be proficient in basic computing software including but not limited to Microsoft Word, Excel, Power Point and Outlook. • Must possess the ability to write both scientifically and analytically. • Must be proficient in statistical analysis Preferred Qualifications • Master s Degree in nursing or research related field. • Certified Clinical Research Associate or Clinical Research Coordinator Credentials. • Principal Investigator Credentials.
Director CMC Project Management Job Scope & Purpose: Our well-funded client is looking for a motivated, dynamic and collaborative Director level CMC Project Manager to join a growing established team focused on translating innovative science into medical breakthroughs for patients. The CMC Project Manager will oversee CDMO activities for partnered CMC projects involving cell therapy product candidates and required starting materials (viral vector, feeders) for all phases of clinical development and beyond. The CMC Project Manager will also work closely with leadership to shape manufacturing and supply strategy and drive operational execution of strategic projects; and with functional leaders to establish a project management practice for internal CMC projects including the preparation and maintenance of project plans and budgets. The ideal candidate will bring a passion for project management and collaboration in a fast-paced biotech environment. Primary Job Responsibilities: Lead CMC project management within Technical Development and Manufacturing; this will begin as an individual contributor role working with matrixed project teams. With portfolio expansion and progression of our pipeline, there will be future potential to expand the team. Drive flawless execution of CMC partnerships in support of strategy. Serve as primary technical point-of-contact, managing communications and responsible for managing meetings, setting agendas, recording minutes in collaboration with counterpart at partner Coordinate completion of agreements, SOWs, invoice payments and manage the overall relationship with the CDMOs Work with Head of Technical Development and Manufacturing and team members to develop and maintain an integrated project plan for CMC activities with timelines, and risks. Interface and coordinate with program management / program strategy team as needed Develop a framework for internal CMC operations to assess progress against goals and report metrics to drive resource allocation, workforce planning and investment decisions Support long-term planning and strategy development and facilitate decision making related to investments in technology, manufacturing cost analysis, and facility / capacity planning. Proactively monitor all CMC deliverables and activities at partner to effectively identify, manage, mitigate, and communicate risks Primary Job Requirements: PhD or advanced scientific/ engineering education preferred but would also consider a highly accomplished BS 10+ years CMC experience in biopharma with at least 3 years' experience as a project manager leading functional or cross-functional teams within a CMC or manufacturing function Strong knowledge and understanding of the CMC development for biologics including regulatory requirements Exceptional project management skills and the ability to build productive partnerships, and communicate, collaborate, and influence effectively throughout all levels of the Company and external partners Prior experience in development of gene therapy and/or cell therapy product for immuno-oncology or other applications would be ideal but is not required. Desire and ability to work in an entrepreneurial, collaborative environment, and manage multiple responsibilities in parallel with minimal direction Proficiency with MS Excel, PowerPoint, and MS Project About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code: TechOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice
10/28/2021
Full time
Director CMC Project Management Job Scope & Purpose: Our well-funded client is looking for a motivated, dynamic and collaborative Director level CMC Project Manager to join a growing established team focused on translating innovative science into medical breakthroughs for patients. The CMC Project Manager will oversee CDMO activities for partnered CMC projects involving cell therapy product candidates and required starting materials (viral vector, feeders) for all phases of clinical development and beyond. The CMC Project Manager will also work closely with leadership to shape manufacturing and supply strategy and drive operational execution of strategic projects; and with functional leaders to establish a project management practice for internal CMC projects including the preparation and maintenance of project plans and budgets. The ideal candidate will bring a passion for project management and collaboration in a fast-paced biotech environment. Primary Job Responsibilities: Lead CMC project management within Technical Development and Manufacturing; this will begin as an individual contributor role working with matrixed project teams. With portfolio expansion and progression of our pipeline, there will be future potential to expand the team. Drive flawless execution of CMC partnerships in support of strategy. Serve as primary technical point-of-contact, managing communications and responsible for managing meetings, setting agendas, recording minutes in collaboration with counterpart at partner Coordinate completion of agreements, SOWs, invoice payments and manage the overall relationship with the CDMOs Work with Head of Technical Development and Manufacturing and team members to develop and maintain an integrated project plan for CMC activities with timelines, and risks. Interface and coordinate with program management / program strategy team as needed Develop a framework for internal CMC operations to assess progress against goals and report metrics to drive resource allocation, workforce planning and investment decisions Support long-term planning and strategy development and facilitate decision making related to investments in technology, manufacturing cost analysis, and facility / capacity planning. Proactively monitor all CMC deliverables and activities at partner to effectively identify, manage, mitigate, and communicate risks Primary Job Requirements: PhD or advanced scientific/ engineering education preferred but would also consider a highly accomplished BS 10+ years CMC experience in biopharma with at least 3 years' experience as a project manager leading functional or cross-functional teams within a CMC or manufacturing function Strong knowledge and understanding of the CMC development for biologics including regulatory requirements Exceptional project management skills and the ability to build productive partnerships, and communicate, collaborate, and influence effectively throughout all levels of the Company and external partners Prior experience in development of gene therapy and/or cell therapy product for immuno-oncology or other applications would be ideal but is not required. Desire and ability to work in an entrepreneurial, collaborative environment, and manage multiple responsibilities in parallel with minimal direction Proficiency with MS Excel, PowerPoint, and MS Project About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code: TechOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice
University of Nebraska Medical Center UNMC
Omaha, Nebraska
Medical Oncology Physician Leadership Opportunity at UNMC The Division of Hematology and Oncology at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska is excited to announce a faculty opportunity for an experienced medical oncologist. This is an exciting opportunity to join more than 200 oncologists, translational and basic scientists working together fusing science and medicine to speed up breakthroughs in the lab and deliver state of the art care to patients. As part of the Big Ten Cancer Research Consortium, a unique team-research culture drives science rapidly from ideas to treatment-changing paradigms. The Fred & Pamela Buffett Cancer Center, the only National Cancer Institute-designated cancer center in Nebraska, provides the best in science and clinical practice. Through collaboration between the UNMCâs Oncology/Hematology Division and our hospital partner, Nebraska Medicine, patients experience personalized care based on the latest scientific research. Opportunity Highlights: Director of Oncology Early Phase Research â¢Lead, manage and direct continued development of the early phase clinical research team including the 24-hour infusion area, nursing education, blood draws for PK's, and data analysis. â¢Oncologist experienced in conducting early phase clinical trials and devotion to clinical care and clinical investigation for oncology required. The selected candidate will enjoy participation in multidisciplinary patient care teams, inpatient treatment, outpatient care, clinical trials and opportunities for collaboration for investigator initiated clinical research, and translational research. Ideal candidates will be board certified in internal medicine and BC/BE in medical oncology and/or hematology. Interest in teaching fellows, residents and medical students required. Must have an MD, DO, or MBBS degree. Faculty rank will be dependent upon qualifications at hire. Inquiries may be directed to: Julie Vose, MD, MBA Interested candidates may apply with CV and letter of interest: Director of Oncology Early Phase Research â Individuals from diverse backgrounds are encouraged to apply.Omaha, NE
09/14/2021
Full time
Medical Oncology Physician Leadership Opportunity at UNMC The Division of Hematology and Oncology at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska is excited to announce a faculty opportunity for an experienced medical oncologist. This is an exciting opportunity to join more than 200 oncologists, translational and basic scientists working together fusing science and medicine to speed up breakthroughs in the lab and deliver state of the art care to patients. As part of the Big Ten Cancer Research Consortium, a unique team-research culture drives science rapidly from ideas to treatment-changing paradigms. The Fred & Pamela Buffett Cancer Center, the only National Cancer Institute-designated cancer center in Nebraska, provides the best in science and clinical practice. Through collaboration between the UNMCâs Oncology/Hematology Division and our hospital partner, Nebraska Medicine, patients experience personalized care based on the latest scientific research. Opportunity Highlights: Director of Oncology Early Phase Research â¢Lead, manage and direct continued development of the early phase clinical research team including the 24-hour infusion area, nursing education, blood draws for PK's, and data analysis. â¢Oncologist experienced in conducting early phase clinical trials and devotion to clinical care and clinical investigation for oncology required. The selected candidate will enjoy participation in multidisciplinary patient care teams, inpatient treatment, outpatient care, clinical trials and opportunities for collaboration for investigator initiated clinical research, and translational research. Ideal candidates will be board certified in internal medicine and BC/BE in medical oncology and/or hematology. Interest in teaching fellows, residents and medical students required. Must have an MD, DO, or MBBS degree. Faculty rank will be dependent upon qualifications at hire. Inquiries may be directed to: Julie Vose, MD, MBA Interested candidates may apply with CV and letter of interest: Director of Oncology Early Phase Research â Individuals from diverse backgrounds are encouraged to apply.Omaha, NE
Cygnal, a new biology platform company, was founded by Flagship Pioneering to pioneer the field of exoneural biology - the impact of the peripheral nervous system on cancer, the immune system, metabolism, and regeneration. The company is applying cutting-edge neuroscience to elucidate novel therapies to treat cancer progression and metastasis, autoimmune conditions, inflammation, and other diseases. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. To date, Flagship is backed by >$3 billion of aggregate capital commitments, of which over $1.4 billion has been deployed toward the founding and growth of its pioneering companies alongside >$10 billion of follow-on investments from other institutions. The current Flagship ecosystem includes Denali Therapeutics (NASDAQ: DNLI ), Evelo Biosciences (NASDAQ: EVLO ), Moderna Therapeutics (NASDAQ: MRNA ), Rubius Therapeutics (NASDAQ: RUBY ), Seres Therapeutics (NASDAQ: MCRB ), and Syros Pharmaceuticals (NASDAQ: SYRS ). The Position Cygnal Therapeutics is seeking a highly experienced, motivated Head of Program Management to join an innovative, scientifically driven, and fast paced team focused on developing therapies for cancer and inflammatory diseases. The successful candidate will report to the Chief Medical Officer and be a self-starter who thrives in a highly collaborative and fast paced environment. The successful candidate will be a highly credible thought partner with senior stakeholders because this will be a high visibility role, both internally and externally. Key Responsibilities Define our project management approach at Cygnal, with a focus on development programs, but also inclusion of discovery activities. Build Cygnal's Project Management infrastructure and capabilities. Operationalize and lead Cygnal Project Management activities, including timelines, Gantt charts, budgets, resourcing, prioritization, risk and issue management, governance, reporting, and decision support. Work closely and collaboratively in a multi-disciplinary team. Operate at both a strategic and high level with internal and external stakeholders, as well as roll sleeves up and be hands on with deliverables. Proactively identify sources of inefficiency and propose novel technologies and collaborations. Minimum Qualifications A. or B.S. in a relevant scientific field 15+ years Project Management, including timelines, Gantt charts, budgets, resourcing, , prioritization, risk and issue management., governance, reporting, and decision support Experience with multiple pre-clinical and clinical programs in parallel Proven ability to manage timelines and resources to drive projects toward key decision point Track record of strong leadership: Open-minded, curious, candid, trust-oriented leadership style Fast learner, flexible and adaptable, internally driven self-starter, self-aware and seeks input/ help when needed, solution focused Keen attention to detail, a strong sense of urgency and ability to work in a multi-disciplinary and team-focused environment Excellent communication and presentation skills, capable of conveying technical information and strategy in a clear and thorough manner Preferred Qualifications Advanced degree (e.g., Ph.D. in a relevant scientific field), P.M.D certification a plus. Oncology experience is desirable Wide experience spanning early and late discovery, early and late development and secondarily commercialization Business Development project management or Alliance Management experience is helpful People Management experience is a plus Recruiting and Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. Contact Information To learn more about this exciting career opportunity please submit your resume and cover letter to .
09/14/2021
Full time
Cygnal, a new biology platform company, was founded by Flagship Pioneering to pioneer the field of exoneural biology - the impact of the peripheral nervous system on cancer, the immune system, metabolism, and regeneration. The company is applying cutting-edge neuroscience to elucidate novel therapies to treat cancer progression and metastasis, autoimmune conditions, inflammation, and other diseases. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. To date, Flagship is backed by >$3 billion of aggregate capital commitments, of which over $1.4 billion has been deployed toward the founding and growth of its pioneering companies alongside >$10 billion of follow-on investments from other institutions. The current Flagship ecosystem includes Denali Therapeutics (NASDAQ: DNLI ), Evelo Biosciences (NASDAQ: EVLO ), Moderna Therapeutics (NASDAQ: MRNA ), Rubius Therapeutics (NASDAQ: RUBY ), Seres Therapeutics (NASDAQ: MCRB ), and Syros Pharmaceuticals (NASDAQ: SYRS ). The Position Cygnal Therapeutics is seeking a highly experienced, motivated Head of Program Management to join an innovative, scientifically driven, and fast paced team focused on developing therapies for cancer and inflammatory diseases. The successful candidate will report to the Chief Medical Officer and be a self-starter who thrives in a highly collaborative and fast paced environment. The successful candidate will be a highly credible thought partner with senior stakeholders because this will be a high visibility role, both internally and externally. Key Responsibilities Define our project management approach at Cygnal, with a focus on development programs, but also inclusion of discovery activities. Build Cygnal's Project Management infrastructure and capabilities. Operationalize and lead Cygnal Project Management activities, including timelines, Gantt charts, budgets, resourcing, prioritization, risk and issue management, governance, reporting, and decision support. Work closely and collaboratively in a multi-disciplinary team. Operate at both a strategic and high level with internal and external stakeholders, as well as roll sleeves up and be hands on with deliverables. Proactively identify sources of inefficiency and propose novel technologies and collaborations. Minimum Qualifications A. or B.S. in a relevant scientific field 15+ years Project Management, including timelines, Gantt charts, budgets, resourcing, , prioritization, risk and issue management., governance, reporting, and decision support Experience with multiple pre-clinical and clinical programs in parallel Proven ability to manage timelines and resources to drive projects toward key decision point Track record of strong leadership: Open-minded, curious, candid, trust-oriented leadership style Fast learner, flexible and adaptable, internally driven self-starter, self-aware and seeks input/ help when needed, solution focused Keen attention to detail, a strong sense of urgency and ability to work in a multi-disciplinary and team-focused environment Excellent communication and presentation skills, capable of conveying technical information and strategy in a clear and thorough manner Preferred Qualifications Advanced degree (e.g., Ph.D. in a relevant scientific field), P.M.D certification a plus. Oncology experience is desirable Wide experience spanning early and late discovery, early and late development and secondarily commercialization Business Development project management or Alliance Management experience is helpful People Management experience is a plus Recruiting and Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. Contact Information To learn more about this exciting career opportunity please submit your resume and cover letter to .
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The Global Medical Affairs Molecule Lead (GMA ML) for NABIXIMOLS is a key member of Jazz's Global Medical Affairs department, reporting directly to Therapy Area Head for Neurosciences, GMA. As the company's subject matter expert for NABIXIMOLS in movement disorders, he/she will hold a key leadership position and be responsible for developing an integrated Global Medical Affairs Strategy and Plan for the molecule. The GMA ML will partner with the Regional and Global Medical Affairs teams to ensure the needs and perspectives of Medical are represented at global matrix teams across the development and commercial lifecycle. As a leader within the business, he/she is expected to partner with senior cross-functional colleagues to ensure effective product lifecycle management. The incumbent will drive the delivery of high quality scientific, medical and strategic communications and evidence generation strategies for the product globally. Job Responsibilities: Ensure the planning and execution of an integrated Global Medical strategy that addresses current and future needs of the business Develop annual and 3-year integrated Global Medical Affairs Plan for NABIXIMOLS, clearly outlining medical strategic imperatives, critical success factors and tactics including evidence generation activities. Lead the annual cross functional global NABIXIMOLS Integrated Evidence Generation Plan (Phase IV & ISTs) development and execution in alignment with the Global Molecule Team (GMT) and Brand Team objectives Develop the NABIXIMOLS core scientific platform, which should encompass disease state(s), the unmet medical needs, and the product's clinical attributes Work closely with the Medical Communications team to craft the NABIXIMOLS communication strategy and publication plan Responsible for developing and executing the Global Medical Affairs pre-approval strategy for new indications Maintain strong scientific knowledge of the Movement Disorders market from both a scientific perspective as well as from the perspective of the current and future competitive landscape Be able to provide medical insights contributing to pipeline growth, due diligence and portfolio development Establish and lead a Medical Core Team, ensuring strong alignment with Regional Medical Affairs and partners. Oversees core Medical Affairs programs and develops KPIs to track success of the Medical strategy and plan Represent the voice of Medical in the GMT and provide a holistic view of Medical Affairs strategy for molecule Provide a clear GMA plan for geographic expansion, based on the company's product pipeline and activity Making sure the business maintains a status of compliance with affiliate and international codes and regulations relevant to the markets in which the business operates Collaborate with other GMA MLs as relevant to ensure alignment around overlapping areas of interest (e.g. disease states, MOA) and the leveraging best practices Essential Qualifications: Doctorate degree required. MD degree preferred. Clinical experience in Neurology and specifically movement disorders is highly desired. Medical Affairs and/or clinical development experience in neurosciences and/or movement Disorders required: Experience developing and executing Global Medical Affairs Strategies and Plans preferred Experience developing and executing company sponsored post marketing evidence generation including RWE preferred Experience working with US, European and International markets preferred Experience leading cross-functional teams required Strong organizational skills, delivering on commitments in a timely manner, while maintaining a strong customer focus. Entrepreneurial thinking, self-starter with positive can-do attitude. High degree of professionalism, integrity and collaboration required. Exceptional verbal and written communication skills. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
09/09/2021
Full time
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The Global Medical Affairs Molecule Lead (GMA ML) for NABIXIMOLS is a key member of Jazz's Global Medical Affairs department, reporting directly to Therapy Area Head for Neurosciences, GMA. As the company's subject matter expert for NABIXIMOLS in movement disorders, he/she will hold a key leadership position and be responsible for developing an integrated Global Medical Affairs Strategy and Plan for the molecule. The GMA ML will partner with the Regional and Global Medical Affairs teams to ensure the needs and perspectives of Medical are represented at global matrix teams across the development and commercial lifecycle. As a leader within the business, he/she is expected to partner with senior cross-functional colleagues to ensure effective product lifecycle management. The incumbent will drive the delivery of high quality scientific, medical and strategic communications and evidence generation strategies for the product globally. Job Responsibilities: Ensure the planning and execution of an integrated Global Medical strategy that addresses current and future needs of the business Develop annual and 3-year integrated Global Medical Affairs Plan for NABIXIMOLS, clearly outlining medical strategic imperatives, critical success factors and tactics including evidence generation activities. Lead the annual cross functional global NABIXIMOLS Integrated Evidence Generation Plan (Phase IV & ISTs) development and execution in alignment with the Global Molecule Team (GMT) and Brand Team objectives Develop the NABIXIMOLS core scientific platform, which should encompass disease state(s), the unmet medical needs, and the product's clinical attributes Work closely with the Medical Communications team to craft the NABIXIMOLS communication strategy and publication plan Responsible for developing and executing the Global Medical Affairs pre-approval strategy for new indications Maintain strong scientific knowledge of the Movement Disorders market from both a scientific perspective as well as from the perspective of the current and future competitive landscape Be able to provide medical insights contributing to pipeline growth, due diligence and portfolio development Establish and lead a Medical Core Team, ensuring strong alignment with Regional Medical Affairs and partners. Oversees core Medical Affairs programs and develops KPIs to track success of the Medical strategy and plan Represent the voice of Medical in the GMT and provide a holistic view of Medical Affairs strategy for molecule Provide a clear GMA plan for geographic expansion, based on the company's product pipeline and activity Making sure the business maintains a status of compliance with affiliate and international codes and regulations relevant to the markets in which the business operates Collaborate with other GMA MLs as relevant to ensure alignment around overlapping areas of interest (e.g. disease states, MOA) and the leveraging best practices Essential Qualifications: Doctorate degree required. MD degree preferred. Clinical experience in Neurology and specifically movement disorders is highly desired. Medical Affairs and/or clinical development experience in neurosciences and/or movement Disorders required: Experience developing and executing Global Medical Affairs Strategies and Plans preferred Experience developing and executing company sponsored post marketing evidence generation including RWE preferred Experience working with US, European and International markets preferred Experience leading cross-functional teams required Strong organizational skills, delivering on commitments in a timely manner, while maintaining a strong customer focus. Entrepreneurial thinking, self-starter with positive can-do attitude. High degree of professionalism, integrity and collaboration required. Exceptional verbal and written communication skills. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The Global Medical Affairs Molecule Lead (GMA ML) for EPIDIOLEX is a key member of Jazz's Global Medical Affairs department, reporting directly to Therapy Area Head for Neurosciences, GMA. As the company's subject matter expert for EPIDIOLEX in seizure disorders, he/she will hold a key leadership position and be responsible for developing an integrated Global Medical Affairs Strategy and Plan for the molecule. The GMA ML will partner with the Regional and Global Medical Affairs teams to ensure the needs and perspectives of Medical are represented at global matrix teams across the development and commercial lifecycle. As a leader within the business, he/she is expected to partner with senior cross-functional colleagues to ensure effective product lifecycle management. The incumbent will drive the delivery of high quality scientific, medical and strategic communications and evidence generation strategies for the product globally. Job Responsibilities: Ensure the planning and execution of an integrated Global Medical strategy that addresses current and future needs of the business Develop annual and 3-year integrated Global Medical Affairs Plan for EPIDIOLEX, clearly outlining medical strategic imperatives, critical success factors and tactics including evidence generation activities. Lead the annual cross functional global EPIDIOLEX Integrated Evidence Generation Plan (Phase IV & ISTs) development and execution in alignment with the Global Molecule Team (GMT) and Brand Team objectives Develop the EPIDIOLEX core scientific platform, which should encompass disease state(s), the unmet medical needs, and the product's clinical attributes Work closely with the Medical Communications team to craft the EPIDIOLEX communication strategy and publication plan Responsible for developing and executing the Global Medical Affairs pre-approval strategy for new indications Maintain strong scientific knowledge of the epilepsy market from both a scientific perspective as well as from the perspective of the current and future competitive landscape Be able to provide medical insights contributing to pipeline growth, due diligence and portfolio development Establish and lead a Medical Core Team, ensuring strong alignment with Regional Medical Affairs and partners. Oversees core Medical Affairs programs and develops KPIs to track success of the Medical strategy and plan Represent the voice of Medical in the GMT and provide a holistic view of Medical Affairs strategy for molecule Provide a clear GMA plan for geographic expansion, based on the company's product pipeline and activity Making sure the business maintains a status of compliance with affiliate and international codes and regulations relevant to the markets in which the business operates Collaborate with other GMA MLs as relevant to ensure alignment around overlapping areas of interest (e.g. disease states, MOA) and the leveraging best practices Essential Qualifications: Doctorate degree required. MD degree preferred. Clinical experience in Neurology and specifically seizure disorders is highly desired. Medical Affairs and/or clinical development experience in neurosciences and/or seizure disorders required: Experience developing and executing Global Medical Affairs Strategies and Plans preferred Experience developing and executing company sponsored post marketing evidence generation including RWE preferred Experience working with US, European and International markets preferred Experience leading cross-functional teams required Strong organizational skills, delivering on commitments in a timely manner, while maintaining a strong customer focus. Entrepreneurial thinking, self-starter with positive can-do attitude. High degree of professionalism, integrity and collaboration required. Exceptional verbal and written communication skills. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
09/09/2021
Full time
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The Global Medical Affairs Molecule Lead (GMA ML) for EPIDIOLEX is a key member of Jazz's Global Medical Affairs department, reporting directly to Therapy Area Head for Neurosciences, GMA. As the company's subject matter expert for EPIDIOLEX in seizure disorders, he/she will hold a key leadership position and be responsible for developing an integrated Global Medical Affairs Strategy and Plan for the molecule. The GMA ML will partner with the Regional and Global Medical Affairs teams to ensure the needs and perspectives of Medical are represented at global matrix teams across the development and commercial lifecycle. As a leader within the business, he/she is expected to partner with senior cross-functional colleagues to ensure effective product lifecycle management. The incumbent will drive the delivery of high quality scientific, medical and strategic communications and evidence generation strategies for the product globally. Job Responsibilities: Ensure the planning and execution of an integrated Global Medical strategy that addresses current and future needs of the business Develop annual and 3-year integrated Global Medical Affairs Plan for EPIDIOLEX, clearly outlining medical strategic imperatives, critical success factors and tactics including evidence generation activities. Lead the annual cross functional global EPIDIOLEX Integrated Evidence Generation Plan (Phase IV & ISTs) development and execution in alignment with the Global Molecule Team (GMT) and Brand Team objectives Develop the EPIDIOLEX core scientific platform, which should encompass disease state(s), the unmet medical needs, and the product's clinical attributes Work closely with the Medical Communications team to craft the EPIDIOLEX communication strategy and publication plan Responsible for developing and executing the Global Medical Affairs pre-approval strategy for new indications Maintain strong scientific knowledge of the epilepsy market from both a scientific perspective as well as from the perspective of the current and future competitive landscape Be able to provide medical insights contributing to pipeline growth, due diligence and portfolio development Establish and lead a Medical Core Team, ensuring strong alignment with Regional Medical Affairs and partners. Oversees core Medical Affairs programs and develops KPIs to track success of the Medical strategy and plan Represent the voice of Medical in the GMT and provide a holistic view of Medical Affairs strategy for molecule Provide a clear GMA plan for geographic expansion, based on the company's product pipeline and activity Making sure the business maintains a status of compliance with affiliate and international codes and regulations relevant to the markets in which the business operates Collaborate with other GMA MLs as relevant to ensure alignment around overlapping areas of interest (e.g. disease states, MOA) and the leveraging best practices Essential Qualifications: Doctorate degree required. MD degree preferred. Clinical experience in Neurology and specifically seizure disorders is highly desired. Medical Affairs and/or clinical development experience in neurosciences and/or seizure disorders required: Experience developing and executing Global Medical Affairs Strategies and Plans preferred Experience developing and executing company sponsored post marketing evidence generation including RWE preferred Experience working with US, European and International markets preferred Experience leading cross-functional teams required Strong organizational skills, delivering on commitments in a timely manner, while maintaining a strong customer focus. Entrepreneurial thinking, self-starter with positive can-do attitude. High degree of professionalism, integrity and collaboration required. Exceptional verbal and written communication skills. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Pionyr Immunotherapeutics
South San Francisco, California
Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking a Clinical Research Associate (CRA). The Clinical Research Associate will be a key member of the clinical team responsible for supporting the planning, successful implementation and management of one or more clinical trial(s). This is an in-house position, and we are looking to hire a local candidate. The CRA will report to Pionyr's Sr. Director, Clinical Operations and will work closely with our clinical operations and regulatory staff. Specific Responsibilities include (but not limited to): Assisting in the development of study protocols, case report forms, clinical reports, site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives. Build effective relationships across all company functional areas that interact with Clinical Operations as well as with personnel at assigned clinical sites. Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements. Responsible for clinical study document archiving according to regulatory and industry standards. Participate in the design of study manuals, document archiving structure, etc. Participate in site start-up, interim and close-out activities, etc. Review study records including case report forms, consent forms and other materials; may perform site visits to ensure regulatory and study requirements are being fulfilled. Assist in tracking and managing shipments of biological specimens and study-related supplies. Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track progress and obstacles and responding to day-to-day problems. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines, Code of Federal Regulations and study-specific plans and procedures. Assist in identification and hiring of appropriate CROs and third-party study vendors. Assist in evaluation of the performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Sr. Director, Clinical Operations. Assist in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices Maintain all trial files and other related documents, including trial master file and oversight of site files Perform other duties as requested Qualifications Bachelor's degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience. Advanced degree(s) in scientific research, nursing, or business is a plus 2-3 years' experience in supporting clinical studies and drug development, within the biotech/pharmaceutical industry 1+ years' experience in the role of Clinical Research Associate preferred Experience in the preparation, monitoring, and execution of clinical studies is a plus Ability to motivate clinical site personnel to maintain/accelerate to achieve clinical operational milestones An understanding and demonstrated application of Good Clinical Practices and ICH Guidelines is a plus. Able to comply with safety standards and respect privacy and confidentiality. Agree to adhere to regulatory and industry standards on document archiving. Superb verbal and written communication skills. Excellent organizational skills along with strong attention to detail. Ability to work collaboratively with cross-functional teams, external vendors and clinical site staff Experience working with Electronic Data Capture systems as well as Microsoft Office applications including MS Word, Excel, PowerPoint and Outlook, Cloud based storage platforms as well as calendaring programs and database applications required. Ability to effectively work in a fast-paced environment supporting multiple priorities Some domestic and international travel may be required for site training, monitoring responsibilities, etc. Ability to travel up to 20%. How to Apply Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume. Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.
03/09/2021
Full time
Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking a Clinical Research Associate (CRA). The Clinical Research Associate will be a key member of the clinical team responsible for supporting the planning, successful implementation and management of one or more clinical trial(s). This is an in-house position, and we are looking to hire a local candidate. The CRA will report to Pionyr's Sr. Director, Clinical Operations and will work closely with our clinical operations and regulatory staff. Specific Responsibilities include (but not limited to): Assisting in the development of study protocols, case report forms, clinical reports, site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives. Build effective relationships across all company functional areas that interact with Clinical Operations as well as with personnel at assigned clinical sites. Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements. Responsible for clinical study document archiving according to regulatory and industry standards. Participate in the design of study manuals, document archiving structure, etc. Participate in site start-up, interim and close-out activities, etc. Review study records including case report forms, consent forms and other materials; may perform site visits to ensure regulatory and study requirements are being fulfilled. Assist in tracking and managing shipments of biological specimens and study-related supplies. Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track progress and obstacles and responding to day-to-day problems. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines, Code of Federal Regulations and study-specific plans and procedures. Assist in identification and hiring of appropriate CROs and third-party study vendors. Assist in evaluation of the performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Sr. Director, Clinical Operations. Assist in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices Maintain all trial files and other related documents, including trial master file and oversight of site files Perform other duties as requested Qualifications Bachelor's degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience. Advanced degree(s) in scientific research, nursing, or business is a plus 2-3 years' experience in supporting clinical studies and drug development, within the biotech/pharmaceutical industry 1+ years' experience in the role of Clinical Research Associate preferred Experience in the preparation, monitoring, and execution of clinical studies is a plus Ability to motivate clinical site personnel to maintain/accelerate to achieve clinical operational milestones An understanding and demonstrated application of Good Clinical Practices and ICH Guidelines is a plus. Able to comply with safety standards and respect privacy and confidentiality. Agree to adhere to regulatory and industry standards on document archiving. Superb verbal and written communication skills. Excellent organizational skills along with strong attention to detail. Ability to work collaboratively with cross-functional teams, external vendors and clinical site staff Experience working with Electronic Data Capture systems as well as Microsoft Office applications including MS Word, Excel, PowerPoint and Outlook, Cloud based storage platforms as well as calendaring programs and database applications required. Ability to effectively work in a fast-paced environment supporting multiple priorities Some domestic and international travel may be required for site training, monitoring responsibilities, etc. Ability to travel up to 20%. How to Apply Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume. Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: This position is hands on role within Arcus Biotechnology's QA organization. The responsibility of the incumbent includes but not limited to quality oversight of GMP Quality Management System, Standard procedures, and Governance Quality Process across organizations. Leading risk management initiatives including risk assessment within quality processes, tracking and trending of Quality Metrics, hand's on support of Supply Chain Quality Operations and QP interactions. The incumbent will also manage CMC documents archived in the company's electronic data management system. Provide training for functional teams, support, and escalate compliance issues to senior management in a timely manner. This is a highly visible role with responsibility and cross-functional influence across departments. It's a role that requires tactical decision-making skills. Job Responsibilities: Oversight of all processes related to management of Arcus GMP Quality System and infrastructure (Deviations, CAPA's Change Control, Complaints, Risk Management, etc.). Lifecycle oversight of Arcus' processes and procedures. Assess current procedures and create new procedures as needed to ensure compliance with industry standards and health authority requirements. Identify opportunities to streamline systems and processes. Manage the maintenance of documentation archived within Arcus' electronic data management system. Responsible for managing and ensuring the archival of all CMC related data. Provide Quality guidance cross functionally to ensure compliance with KPI targets. Monitor performance metrics and drive continuous improvements of internal processes. Manage and facilitate ongoing Quality Management Review. Lead and execute projects related to PQS to support data-driven QA development processes Support regulatory filings and inspection as needed Representation of QA across the organization by providing GMP guidance during training. Responsible for supply chain quality oversight. Support CMO packaging, labeling, and logistics operations. Manage batch traceability (genealogy) of packaged clinical materials. Manage product complains and temperature excursions. Responsible for QP interactions Other duties as assigned Qualifications (including knowledge & skills): Bachelor of Science degree, in a related scientific discipline Core Competencies, Knowledge and Skill Requirements In-depth knowledge of GMPs (EU, US, AU, JP) Experience in working with external partners and/or contract manufacturing In-depth knowledge of Quality principles, concepts, industry practices and standards Excellent verbal, written and interpersonal communication skills Ability to work independently with scientific/technical personnel Knowledge of risk management tools Communication & Interpersonal Skills Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail Significant Contacts Interacts with all levels of Arcus Bio employees including CMOs
03/03/2021
Full time
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: This position is hands on role within Arcus Biotechnology's QA organization. The responsibility of the incumbent includes but not limited to quality oversight of GMP Quality Management System, Standard procedures, and Governance Quality Process across organizations. Leading risk management initiatives including risk assessment within quality processes, tracking and trending of Quality Metrics, hand's on support of Supply Chain Quality Operations and QP interactions. The incumbent will also manage CMC documents archived in the company's electronic data management system. Provide training for functional teams, support, and escalate compliance issues to senior management in a timely manner. This is a highly visible role with responsibility and cross-functional influence across departments. It's a role that requires tactical decision-making skills. Job Responsibilities: Oversight of all processes related to management of Arcus GMP Quality System and infrastructure (Deviations, CAPA's Change Control, Complaints, Risk Management, etc.). Lifecycle oversight of Arcus' processes and procedures. Assess current procedures and create new procedures as needed to ensure compliance with industry standards and health authority requirements. Identify opportunities to streamline systems and processes. Manage the maintenance of documentation archived within Arcus' electronic data management system. Responsible for managing and ensuring the archival of all CMC related data. Provide Quality guidance cross functionally to ensure compliance with KPI targets. Monitor performance metrics and drive continuous improvements of internal processes. Manage and facilitate ongoing Quality Management Review. Lead and execute projects related to PQS to support data-driven QA development processes Support regulatory filings and inspection as needed Representation of QA across the organization by providing GMP guidance during training. Responsible for supply chain quality oversight. Support CMO packaging, labeling, and logistics operations. Manage batch traceability (genealogy) of packaged clinical materials. Manage product complains and temperature excursions. Responsible for QP interactions Other duties as assigned Qualifications (including knowledge & skills): Bachelor of Science degree, in a related scientific discipline Core Competencies, Knowledge and Skill Requirements In-depth knowledge of GMPs (EU, US, AU, JP) Experience in working with external partners and/or contract manufacturing In-depth knowledge of Quality principles, concepts, industry practices and standards Excellent verbal, written and interpersonal communication skills Ability to work independently with scientific/technical personnel Knowledge of risk management tools Communication & Interpersonal Skills Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail Significant Contacts Interacts with all levels of Arcus Bio employees including CMOs
DESCRIPTION The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU. MAJOR RESPONSIBILITIES AND DUTIES Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries; Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators; Liason with US FDA, EU and other regulatory authorities as assigned; Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU; Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development; Ensure compilation of electronic submissions according to current health authority standards; Provide regulatory oversight by developing and implementing SOP's; Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects Additional Skills & Qualifications: BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals NDA or BLA filing experience a plus Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines Good leadership, organization, problem-solving & communication skills Excellent written and oral communication skills Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus Knowledge of EU regulatory regulations a plus Ability to manage priorities and workflow, managing multiple projects and meeting deadlines Acute attention to detail Good judgement with the ability to make timely and sound decisions Skills: Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical Top Skills Details: regulatory affairs, regulatory Strategy, FDA submission experience Experience Level: Expert Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
01/31/2021
Full time
DESCRIPTION The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU. MAJOR RESPONSIBILITIES AND DUTIES Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries; Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators; Liason with US FDA, EU and other regulatory authorities as assigned; Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU; Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development; Ensure compilation of electronic submissions according to current health authority standards; Provide regulatory oversight by developing and implementing SOP's; Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects Additional Skills & Qualifications: BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals NDA or BLA filing experience a plus Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines Good leadership, organization, problem-solving & communication skills Excellent written and oral communication skills Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus Knowledge of EU regulatory regulations a plus Ability to manage priorities and workflow, managing multiple projects and meeting deadlines Acute attention to detail Good judgement with the ability to make timely and sound decisions Skills: Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical Top Skills Details: regulatory affairs, regulatory Strategy, FDA submission experience Experience Level: Expert Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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 Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% 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 Executive Director, Global Brand Lead- Oncology Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
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 Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% 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 Executive Director, Global Brand Lead- Oncology Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
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 Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% 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 Executive Director, Global Brand Lead- Oncology Non Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
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 Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% 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 Executive Director, Global Brand Lead- Oncology Non Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
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 Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% 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 Executive Director, Global Brand Lead- Oncology ADC City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
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 Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% 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 Executive Director, Global Brand Lead- Oncology ADC City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
Join a Legacy of Innovation 110 Years and Counting! With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary: Medical Affairs leader for assigned compound under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management. May have direct reports. Responsibilities: Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective. Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Lead the team with sleeves rolled up, model the way and enable the team to act. Provides medical leadership to GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound. Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations. Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively. Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall GMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. Manage budgets and resources efficiently for GMA supported activities within the GMA plan, in collaboration with GMA Franchise Head. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Required Experience and Skills Doctorate required, PhD, PharmD, or MD Must have oncology experience, specifically in solid tumors 10+ years pharma, minimum of 5 years of (in-house) medical affairs experience, global preferred Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.) Relationships with key opinion leaders Proven ability to manage multiple priorities at one time Preference Skills Knowledge of ADC or other biologics, or small molecules Demonstrated experience working with an alliance partner company 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, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
01/26/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary: Medical Affairs leader for assigned compound under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management. May have direct reports. Responsibilities: Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective. Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Lead the team with sleeves rolled up, model the way and enable the team to act. Provides medical leadership to GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound. Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations. Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively. Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall GMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. Manage budgets and resources efficiently for GMA supported activities within the GMA plan, in collaboration with GMA Franchise Head. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Required Experience and Skills Doctorate required, PhD, PharmD, or MD Must have oncology experience, specifically in solid tumors 10+ years pharma, minimum of 5 years of (in-house) medical affairs experience, global preferred Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.) Relationships with key opinion leaders Proven ability to manage multiple priorities at one time Preference Skills Knowledge of ADC or other biologics, or small molecules Demonstrated experience working with an alliance partner company 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, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
Nurix has a place for an extraordinary, highly motivated, and accomplished Director/Senior Director, Clinical Scientist. As an integral member of the Clinical Development Team, this person will help to develop innovative solutions for the clinical development of Nurix's pioneering protein modulation programs in hematology, oncology, and cell therapy. Working in close collaboration with the study teams, the incumbent will provide scientific guidance and support. This role will is responsible for various aspects of clinical study design and execution including: protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings. In addition, this role will be responsible for providing supporting rationale for clinical development working closely with the Head of Development. Job Responsibilities: Participate in and contribute to cross-functional clinical development teams with strong ability to work closely with all team members, address study or other program-specific questions. Develop the Global Development plan with senior clinical development staff Implement Global Development Plan with strategic clinical science support Assist in reviewing and authoring clinical protocol. Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision making. Prepare clinical portions of all relevant regulatory filings and meeting packages (INDs, Annual Reports, meeting requests, NDAs, etc.) for US and ex-US Health Authorities. Integrate scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered, high quality studies. Acquire and utilize knowledge of clinical trial design and relevant disease indications to assist in study concept and protocol development. Contribute to discussions concerning scientific and procedural aspects of study design. Coordinate with departments to produce the final protocol and informed consent documents. Compose medical data review plans, Data Safety Monitoring Board (DSMB), Safety Review Committee (SRC) charters, and specific sections of study manuals and investigator meeting materials. Contribute significantly to the development of CRFs, data edit checks, patient profile design, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis. Lead internal clinical data review meetings in conjunction with the medical monitor; lead the data preparation effort for dose escalation meeting, as applicable to study stage. Coordinate and manage external medical advisory committees for the study team such as DSMBs and Scientific Steering Committees, in conjunction with the medical monitor. Research and summarize published literature for continual learning and to prepare training materials for other clinical team members. Contribute to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data, as appropriate. Address investigator questions regarding protocol and related scientific issues and attend site initiation visits (SIVs), in coordination with the medical monitor. Assist in determining the activities to support a project's priorities within functional area Trains other clinical scientists as needed. Basic Qualifications Advanced degree (MD, PhD, or PharmD) and 8+ year's relevant drug development experience Preferred Qualifications Experience directly in the clinical science role, in a hematology/oncology indication for first-in-human and proof of concept studies in small molecules and/or cell therapy. Registrational or Phase 3 study experience is preferred. In depth understanding of clinical operations and translational medicine. Excellent interpersonal skills. Able to translate technical concepts into accessible language and direction for the broader study team. Excellent attention to detail, partnership and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines. Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as Spotfire and Medidata Rave or similar. Strong understanding of ICH GCP, as well as general knowledge of industry practices and standards Commitment to patient safety and clinical compliance. Fit with Nurix Culture and Values Strong team orientation; highly collaborative Solutions and results-oriented focus Hands-on approach; resourceful and open to diverse points of view Company Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
01/26/2021
Full time
Nurix has a place for an extraordinary, highly motivated, and accomplished Director/Senior Director, Clinical Scientist. As an integral member of the Clinical Development Team, this person will help to develop innovative solutions for the clinical development of Nurix's pioneering protein modulation programs in hematology, oncology, and cell therapy. Working in close collaboration with the study teams, the incumbent will provide scientific guidance and support. This role will is responsible for various aspects of clinical study design and execution including: protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings. In addition, this role will be responsible for providing supporting rationale for clinical development working closely with the Head of Development. Job Responsibilities: Participate in and contribute to cross-functional clinical development teams with strong ability to work closely with all team members, address study or other program-specific questions. Develop the Global Development plan with senior clinical development staff Implement Global Development Plan with strategic clinical science support Assist in reviewing and authoring clinical protocol. Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision making. Prepare clinical portions of all relevant regulatory filings and meeting packages (INDs, Annual Reports, meeting requests, NDAs, etc.) for US and ex-US Health Authorities. Integrate scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered, high quality studies. Acquire and utilize knowledge of clinical trial design and relevant disease indications to assist in study concept and protocol development. Contribute to discussions concerning scientific and procedural aspects of study design. Coordinate with departments to produce the final protocol and informed consent documents. Compose medical data review plans, Data Safety Monitoring Board (DSMB), Safety Review Committee (SRC) charters, and specific sections of study manuals and investigator meeting materials. Contribute significantly to the development of CRFs, data edit checks, patient profile design, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis. Lead internal clinical data review meetings in conjunction with the medical monitor; lead the data preparation effort for dose escalation meeting, as applicable to study stage. Coordinate and manage external medical advisory committees for the study team such as DSMBs and Scientific Steering Committees, in conjunction with the medical monitor. Research and summarize published literature for continual learning and to prepare training materials for other clinical team members. Contribute to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data, as appropriate. Address investigator questions regarding protocol and related scientific issues and attend site initiation visits (SIVs), in coordination with the medical monitor. Assist in determining the activities to support a project's priorities within functional area Trains other clinical scientists as needed. Basic Qualifications Advanced degree (MD, PhD, or PharmD) and 8+ year's relevant drug development experience Preferred Qualifications Experience directly in the clinical science role, in a hematology/oncology indication for first-in-human and proof of concept studies in small molecules and/or cell therapy. Registrational or Phase 3 study experience is preferred. In depth understanding of clinical operations and translational medicine. Excellent interpersonal skills. Able to translate technical concepts into accessible language and direction for the broader study team. Excellent attention to detail, partnership and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines. Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as Spotfire and Medidata Rave or similar. Strong understanding of ICH GCP, as well as general knowledge of industry practices and standards Commitment to patient safety and clinical compliance. Fit with Nurix Culture and Values Strong team orientation; highly collaborative Solutions and results-oriented focus Hands-on approach; resourceful and open to diverse points of view Company Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
Look for more than answers. At Quest, we are on a continuous journey of discovery and development. It's this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast-moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people. As a Senior Bioinformatics and Computational Biology Scientist, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing. This is an on-site position based in Lewisville, TX. Senior Bioinformatics and Computational Biology Scientist - the role The Senior Bioinformatics and Computational Biology Scientist will evaluate, develop, validate, implement and support new next-generation sequencing (NGS) data analysis technology and technology enhancements, including bioinformatics analysis pipelines, algorithms, testing/validation scripts, and other tools related to genetic diagnostics. This professional will consult on process and technology improvements within R&D, Operations, Quality Assurance and IT departments, and will participate in resolution of support requests where computational biology tools are used. Med Fusion is a Quest Diagnostics Precision Oncology Center of Excellence and a full-service laboratory and clinical trials service organization. Our core oncology products provide specific answers that clinicians need to deliver the appropriate diagnostic and/or prognostic care to oncology patients throughout the United States. As a member of the med fusion/Quest Diagnostics Bioinformatics team, you will focus on general bioinformatics/computational biological needs of the company, interfacing with both R&D and clinical operations. On the R&D side, your projects will revolve around new product development that require massive data profiling and use these features to generate standardized data sets. Standardized data sets are crucial for rapid pipeline development, timely product releases, and reduced validation costs. On the clinical side, you will support Technical and Scientific Directors to resolve challenging cases, provide ad hoc data queries and troubleshoot issues arising with our clinical workflows when needed. In addition, the Senior Bioinformatics and Computational Biology Scientist will: Work in collaboration with key scientific personnel and the Bioinformatics Engineers to build, test, adapt, support and validate clinical-grade variant analysis pipelines Profile NGS data (Illumina/ThermoFisher) for platform-specific patterns and synthetic data modeling Create standardized NGS datasets to be used throughout testing and validation of our ever-expanding clinical-grade pipelines across multiple sites Support R&D and clinical operations with ad hoc data queries, troubleshooting database and data-flow issues Generation of reports (operational support, experimental QC review, client-delivered clinical reports, etc.) Aid in the design and implementation of bioinformatic databases Regularly reports progress and prepares data analyses for internal review Exercises technical leadership in devising approaches to meet project objectives Prepares reports and analysis of results as related to product/process development and improvement Guides and mentors other scientists and project team members to accomplish project objectives Interprets results of analyses and recommends alternative analyses Provides leadership in technical decisions affecting product development issues. Identifies problems, investigates alternatives and recommends possible courses of action Prepares and/or contributes to articles for publication. Presents information at project meetings, scientific meetings or to customers. Attends technical conferences or seminars To qualify, the ideal candidate will have the following skills and experience: B.S. degree (+6 years), M.S. degree (+4 years) or Ph.D. (+2 years) in advanced science, engineering, or computer science degree Demonstrated proficiency in algorithm development for the analysis of large NGS datasets Demonstrated proficiency in programming for compiled languages (C/C++, D, Java) and/or scripting languages (Perl, Python, R, JavaScript, etc.) Demonstrated proficiency in presenting massive amounts of data in a clean and functional way Demonstrated proficiency in manipulating large NGS datasets: data transformation, read trimming, alignment, variant calling, and data store migration Proficiency working in Unix/Linux operating systems required; Cloud, and/or HPC environment strongly preferred Proficiency in commonly used command-line NGS tools (BWA, SAMTools, Bowtie2, Picard, PINDEL, GATK, etc.) Ability to understand and communicate statistical measures for interrogating the quality of data manipulation Demonstrated ability to communicate efficiently and work effectively with a team of scientists Demonstrated capacity for innovation Knowledge of SQL database development a plus Excellent verbal and written communication skills required Project management and/or support experience a plus Apply Today Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better. Your Quest career. Seek it out. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity or Citizenship.
01/23/2021
Full time
Look for more than answers. At Quest, we are on a continuous journey of discovery and development. It's this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast-moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people. As a Senior Bioinformatics and Computational Biology Scientist, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing. This is an on-site position based in Lewisville, TX. Senior Bioinformatics and Computational Biology Scientist - the role The Senior Bioinformatics and Computational Biology Scientist will evaluate, develop, validate, implement and support new next-generation sequencing (NGS) data analysis technology and technology enhancements, including bioinformatics analysis pipelines, algorithms, testing/validation scripts, and other tools related to genetic diagnostics. This professional will consult on process and technology improvements within R&D, Operations, Quality Assurance and IT departments, and will participate in resolution of support requests where computational biology tools are used. Med Fusion is a Quest Diagnostics Precision Oncology Center of Excellence and a full-service laboratory and clinical trials service organization. Our core oncology products provide specific answers that clinicians need to deliver the appropriate diagnostic and/or prognostic care to oncology patients throughout the United States. As a member of the med fusion/Quest Diagnostics Bioinformatics team, you will focus on general bioinformatics/computational biological needs of the company, interfacing with both R&D and clinical operations. On the R&D side, your projects will revolve around new product development that require massive data profiling and use these features to generate standardized data sets. Standardized data sets are crucial for rapid pipeline development, timely product releases, and reduced validation costs. On the clinical side, you will support Technical and Scientific Directors to resolve challenging cases, provide ad hoc data queries and troubleshoot issues arising with our clinical workflows when needed. In addition, the Senior Bioinformatics and Computational Biology Scientist will: Work in collaboration with key scientific personnel and the Bioinformatics Engineers to build, test, adapt, support and validate clinical-grade variant analysis pipelines Profile NGS data (Illumina/ThermoFisher) for platform-specific patterns and synthetic data modeling Create standardized NGS datasets to be used throughout testing and validation of our ever-expanding clinical-grade pipelines across multiple sites Support R&D and clinical operations with ad hoc data queries, troubleshooting database and data-flow issues Generation of reports (operational support, experimental QC review, client-delivered clinical reports, etc.) Aid in the design and implementation of bioinformatic databases Regularly reports progress and prepares data analyses for internal review Exercises technical leadership in devising approaches to meet project objectives Prepares reports and analysis of results as related to product/process development and improvement Guides and mentors other scientists and project team members to accomplish project objectives Interprets results of analyses and recommends alternative analyses Provides leadership in technical decisions affecting product development issues. Identifies problems, investigates alternatives and recommends possible courses of action Prepares and/or contributes to articles for publication. Presents information at project meetings, scientific meetings or to customers. Attends technical conferences or seminars To qualify, the ideal candidate will have the following skills and experience: B.S. degree (+6 years), M.S. degree (+4 years) or Ph.D. (+2 years) in advanced science, engineering, or computer science degree Demonstrated proficiency in algorithm development for the analysis of large NGS datasets Demonstrated proficiency in programming for compiled languages (C/C++, D, Java) and/or scripting languages (Perl, Python, R, JavaScript, etc.) Demonstrated proficiency in presenting massive amounts of data in a clean and functional way Demonstrated proficiency in manipulating large NGS datasets: data transformation, read trimming, alignment, variant calling, and data store migration Proficiency working in Unix/Linux operating systems required; Cloud, and/or HPC environment strongly preferred Proficiency in commonly used command-line NGS tools (BWA, SAMTools, Bowtie2, Picard, PINDEL, GATK, etc.) Ability to understand and communicate statistical measures for interrogating the quality of data manipulation Demonstrated ability to communicate efficiently and work effectively with a team of scientists Demonstrated capacity for innovation Knowledge of SQL database development a plus Excellent verbal and written communication skills required Project management and/or support experience a plus Apply Today Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better. Your Quest career. Seek it out. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity or Citizenship.