Job Description Position can sit in our Lake County, IL or Bay Area offices. Manager or Associate Director level depending on experience. The Associate Director/Manager, HEOR works independently while under the supervision of the Director to develop and execute outcomes research to demonstrate the value of AbbVie's products both globally and for the U.S. market. He/She develops outcomes research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple product / indications. This research includes: creation of economic models (budget impact and cost effectiveness), conduct of claims analyses and observational research studies / analyses, and the development and validation of Patient Reported Outcomes (PRO) measures, and analyses of PRO data. In addition, he/she leads completion of systematic literature reviews, meta-analyses, and U.S. / Global evidence dossiers. This is accomplished through cross-functional collaboration with internal groups including Clinical Development and Operations; Epidemiology; Regulatory Affairs; Medical Affairs; Commercial; and Global / Regional Market Access. He/She presents health outcomes research findings internally to AbbVie and externally via the peer-reviewed process. In addition, the Associate Director/Manager builds research relationships with key clinical and outcomes thought leaders, resulting in research collaboration. Responsibilities: Develops conceptual framework for economic model and required analysis to populate model Creates and / or manages the creation of the economic model and supporting material Manages creation and revisement of Outcomes Research Plan (e.g., strategic imperatives, value messages, research priorities) Synthesizes data in the creation of value messages for use in dossiers Conducts research gap analysis, drafts / revises protocol synopsis, develops statistical analysis plan for real-world evidence and other outcomes research studies Leads development, validation, submission, licensing, and administration of Patient Reported Outcomes (PRO) measures for randomized controlled trials (RCTs) / observational studies Identifies and assesses research gaps and objectives / studies across key partners and therapeutic areas (TAs) to determine appropriate outcomes research strategy, research objectives, studies, and tactical plan Establishes and manages strategy and execution for product / indication Outcomes Research Plan (includes research, dossier, and communication plans) with oversight of the Director Represents Health Economics and Outcomes Research (HEOR) on various cross-functional teams (e.g., Brand teams) for multiple product / indications Manages strategy and execution for primary / secondary data collection, economic modeling, and PRO research for multiple product / indications Manages and conducts evidence generation and documentation (e.g., gap analysis strategy, model scope and framework, protocol synopsis, study reports, and stakeholder training and communications) Participates in Advisory Boards and interfaces with top thought leaders to conduct research Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses Provides support to the department on health outcomes technical specialty areas (e.g., economic modeling techniques to ensure health technology assessments (HTAs) needs are met globally, PRO methods, and understanding regulatory requirements to obtain PROs on labels) Helps anticipate and lead development of strategies and tactics to support department operational needs
04/07/2024
Full time
Job Description Position can sit in our Lake County, IL or Bay Area offices. Manager or Associate Director level depending on experience. The Associate Director/Manager, HEOR works independently while under the supervision of the Director to develop and execute outcomes research to demonstrate the value of AbbVie's products both globally and for the U.S. market. He/She develops outcomes research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple product / indications. This research includes: creation of economic models (budget impact and cost effectiveness), conduct of claims analyses and observational research studies / analyses, and the development and validation of Patient Reported Outcomes (PRO) measures, and analyses of PRO data. In addition, he/she leads completion of systematic literature reviews, meta-analyses, and U.S. / Global evidence dossiers. This is accomplished through cross-functional collaboration with internal groups including Clinical Development and Operations; Epidemiology; Regulatory Affairs; Medical Affairs; Commercial; and Global / Regional Market Access. He/She presents health outcomes research findings internally to AbbVie and externally via the peer-reviewed process. In addition, the Associate Director/Manager builds research relationships with key clinical and outcomes thought leaders, resulting in research collaboration. Responsibilities: Develops conceptual framework for economic model and required analysis to populate model Creates and / or manages the creation of the economic model and supporting material Manages creation and revisement of Outcomes Research Plan (e.g., strategic imperatives, value messages, research priorities) Synthesizes data in the creation of value messages for use in dossiers Conducts research gap analysis, drafts / revises protocol synopsis, develops statistical analysis plan for real-world evidence and other outcomes research studies Leads development, validation, submission, licensing, and administration of Patient Reported Outcomes (PRO) measures for randomized controlled trials (RCTs) / observational studies Identifies and assesses research gaps and objectives / studies across key partners and therapeutic areas (TAs) to determine appropriate outcomes research strategy, research objectives, studies, and tactical plan Establishes and manages strategy and execution for product / indication Outcomes Research Plan (includes research, dossier, and communication plans) with oversight of the Director Represents Health Economics and Outcomes Research (HEOR) on various cross-functional teams (e.g., Brand teams) for multiple product / indications Manages strategy and execution for primary / secondary data collection, economic modeling, and PRO research for multiple product / indications Manages and conducts evidence generation and documentation (e.g., gap analysis strategy, model scope and framework, protocol synopsis, study reports, and stakeholder training and communications) Participates in Advisory Boards and interfaces with top thought leaders to conduct research Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses Provides support to the department on health outcomes technical specialty areas (e.g., economic modeling techniques to ensure health technology assessments (HTAs) needs are met globally, PRO methods, and understanding regulatory requirements to obtain PROs on labels) Helps anticipate and lead development of strategies and tactics to support department operational needs
Job Description Position can sit in our Lake County, IL or Bay Area offices. Manager or Associate Director level depending on experience. The Associate Director/Manager, HEOR works independently while under the supervision of the Director to develop and execute outcomes research to demonstrate the value of AbbVie's products both globally and for the U.S. market. He/She develops outcomes research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple product / indications. This research includes: creation of economic models (budget impact and cost effectiveness), conduct of claims analyses and observational research studies / analyses, and the development and validation of Patient Reported Outcomes (PRO) measures, and analyses of PRO data. In addition, he/she leads completion of systematic literature reviews, meta-analyses, and U.S. / Global evidence dossiers. This is accomplished through cross-functional collaboration with internal groups including Clinical Development and Operations; Epidemiology; Regulatory Affairs; Medical Affairs; Commercial; and Global / Regional Market Access. He/She presents health outcomes research findings internally to AbbVie and externally via the peer-reviewed process. In addition, the Associate Director/Manager builds research relationships with key clinical and outcomes thought leaders, resulting in research collaboration. Responsibilities: Develops conceptual framework for economic model and required analysis to populate model Creates and / or manages the creation of the economic model and supporting material Manages creation and revisement of Outcomes Research Plan (e.g., strategic imperatives, value messages, research priorities) Synthesizes data in the creation of value messages for use in dossiers Conducts research gap analysis, drafts / revises protocol synopsis, develops statistical analysis plan for real-world evidence and other outcomes research studies Leads development, validation, submission, licensing, and administration of Patient Reported Outcomes (PRO) measures for randomized controlled trials (RCTs) / observational studies Identifies and assesses research gaps and objectives / studies across key partners and therapeutic areas (TAs) to determine appropriate outcomes research strategy, research objectives, studies, and tactical plan Establishes and manages strategy and execution for product / indication Outcomes Research Plan (includes research, dossier, and communication plans) with oversight of the Director Represents Health Economics and Outcomes Research (HEOR) on various cross-functional teams (e.g., Brand teams) for multiple product / indications Manages strategy and execution for primary / secondary data collection, economic modeling, and PRO research for multiple product / indications Manages and conducts evidence generation and documentation (e.g., gap analysis strategy, model scope and framework, protocol synopsis, study reports, and stakeholder training and communications) Participates in Advisory Boards and interfaces with top thought leaders to conduct research Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses Provides support to the department on health outcomes technical specialty areas (e.g., economic modeling techniques to ensure health technology assessments (HTAs) needs are met globally, PRO methods, and understanding regulatory requirements to obtain PROs on labels) Helps anticipate and lead development of strategies and tactics to support department operational needs
04/07/2024
Full time
Job Description Position can sit in our Lake County, IL or Bay Area offices. Manager or Associate Director level depending on experience. The Associate Director/Manager, HEOR works independently while under the supervision of the Director to develop and execute outcomes research to demonstrate the value of AbbVie's products both globally and for the U.S. market. He/She develops outcomes research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple product / indications. This research includes: creation of economic models (budget impact and cost effectiveness), conduct of claims analyses and observational research studies / analyses, and the development and validation of Patient Reported Outcomes (PRO) measures, and analyses of PRO data. In addition, he/she leads completion of systematic literature reviews, meta-analyses, and U.S. / Global evidence dossiers. This is accomplished through cross-functional collaboration with internal groups including Clinical Development and Operations; Epidemiology; Regulatory Affairs; Medical Affairs; Commercial; and Global / Regional Market Access. He/She presents health outcomes research findings internally to AbbVie and externally via the peer-reviewed process. In addition, the Associate Director/Manager builds research relationships with key clinical and outcomes thought leaders, resulting in research collaboration. Responsibilities: Develops conceptual framework for economic model and required analysis to populate model Creates and / or manages the creation of the economic model and supporting material Manages creation and revisement of Outcomes Research Plan (e.g., strategic imperatives, value messages, research priorities) Synthesizes data in the creation of value messages for use in dossiers Conducts research gap analysis, drafts / revises protocol synopsis, develops statistical analysis plan for real-world evidence and other outcomes research studies Leads development, validation, submission, licensing, and administration of Patient Reported Outcomes (PRO) measures for randomized controlled trials (RCTs) / observational studies Identifies and assesses research gaps and objectives / studies across key partners and therapeutic areas (TAs) to determine appropriate outcomes research strategy, research objectives, studies, and tactical plan Establishes and manages strategy and execution for product / indication Outcomes Research Plan (includes research, dossier, and communication plans) with oversight of the Director Represents Health Economics and Outcomes Research (HEOR) on various cross-functional teams (e.g., Brand teams) for multiple product / indications Manages strategy and execution for primary / secondary data collection, economic modeling, and PRO research for multiple product / indications Manages and conducts evidence generation and documentation (e.g., gap analysis strategy, model scope and framework, protocol synopsis, study reports, and stakeholder training and communications) Participates in Advisory Boards and interfaces with top thought leaders to conduct research Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses Provides support to the department on health outcomes technical specialty areas (e.g., economic modeling techniques to ensure health technology assessments (HTAs) needs are met globally, PRO methods, and understanding regulatory requirements to obtain PROs on labels) Helps anticipate and lead development of strategies and tactics to support department operational needs
Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Influences the department and is recognized as an expert resource on label topics. Ensures that labeling data is identified, obtained, and effectively presented for the registration of products worldwide. Represents the organization at Senior level meetings regarding Target Product Label (TPL), Development Core Data Sheet (DCDS), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (EU SPCs) and other Global Labeling. Under the direction of the Director of Strategic Labeling, establishes labeling policy compliant with changing regulatory environment. Manages labeling staff. Develops and supervises regulatory personnel. Responsibilities: Develops and directs regulatory label planning for or across assigned product group, area or operational activity and ensures they are in-line with business needs. Presents process, strategy, and product labeling at Senior level meetings (Global Regulatory Forum (GRF), Executive Leadership Committee (ELC), Common Technical Document (CTD) steering committee) and joint company meetings. Ensures that agreed regulatory labeling strategies or commercial concepts are efficiently implemented, and that strategies are maintained in-line with changing regulatory and business needs. Drives strategic labeling processes within teams based on knowledge of success with other products. Proactively recommends optimal label language based on competitive knowledge and knowledge of project data. Works cross functionally with teams such as Research & Development (R&D) and commercial to meet regulatory labeling needs. Provides labeling input for Risk Management Plans, Regulatory Strategic and Tactical Plan (RSTPs) and safety document. Comments on changing regulation and guidance, interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics/information. Develops and implements internal and external strategies to proactively address changes in the regulatory labeling environment. Under the direction of the Director, Global Labeling, provides regulatory leadership and expertise to licensing colleagues for labeling topics. Develops and manages an effective team. Conducts succession planning. Manages the work of direct reports. Trains new personnel and sets direction for development of new department processes/policies. Leads cross functional teams including regulatory, clinical and safety on labeling topics. Significant Work Activities -Keyboard use (greater or equal to 50% of the workday)
03/30/2024
Full time
Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Influences the department and is recognized as an expert resource on label topics. Ensures that labeling data is identified, obtained, and effectively presented for the registration of products worldwide. Represents the organization at Senior level meetings regarding Target Product Label (TPL), Development Core Data Sheet (DCDS), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (EU SPCs) and other Global Labeling. Under the direction of the Director of Strategic Labeling, establishes labeling policy compliant with changing regulatory environment. Manages labeling staff. Develops and supervises regulatory personnel. Responsibilities: Develops and directs regulatory label planning for or across assigned product group, area or operational activity and ensures they are in-line with business needs. Presents process, strategy, and product labeling at Senior level meetings (Global Regulatory Forum (GRF), Executive Leadership Committee (ELC), Common Technical Document (CTD) steering committee) and joint company meetings. Ensures that agreed regulatory labeling strategies or commercial concepts are efficiently implemented, and that strategies are maintained in-line with changing regulatory and business needs. Drives strategic labeling processes within teams based on knowledge of success with other products. Proactively recommends optimal label language based on competitive knowledge and knowledge of project data. Works cross functionally with teams such as Research & Development (R&D) and commercial to meet regulatory labeling needs. Provides labeling input for Risk Management Plans, Regulatory Strategic and Tactical Plan (RSTPs) and safety document. Comments on changing regulation and guidance, interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics/information. Develops and implements internal and external strategies to proactively address changes in the regulatory labeling environment. Under the direction of the Director, Global Labeling, provides regulatory leadership and expertise to licensing colleagues for labeling topics. Develops and manages an effective team. Conducts succession planning. Manages the work of direct reports. Trains new personnel and sets direction for development of new department processes/policies. Leads cross functional teams including regulatory, clinical and safety on labeling topics. Significant Work Activities -Keyboard use (greater or equal to 50% of the workday)
Job Description Responsibilities: Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. May oversee the work of Associate or Assistant Scientific Directors and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; 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 Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a 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.
03/29/2024
Full time
Job Description Responsibilities: Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. May oversee the work of Associate or Assistant Scientific Directors and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; 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 Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a 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.
Allogene Therapeutics
South San Francisco, California
About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1
08/31/2021
Full time
About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1
About Lumen Lumen is guided by our belief that humanity is at its best when technology advances the way we live and work. With 450,000 route fiber miles serving customers in more than 60 countries, we deliver the fastest, most secure global platform for applications and data to help businesses, government and communities deliver amazing experiences. Learn more about Lumen's network, edge cloud, security and communication and collaboration solutions and our purpose to further human progress through technology at news.lumen.com, LinkedIn: /lumentechnologies, Facebook: /lumentechnologies, and YouTube: /lumentechnologies. The Role The Senior Corporate Counsel reports to an Associate General Counsel - Government Affairs and Public Policy in the company's State Government Affairs organization, serving as Lumen's attorney in matters before various state public utility commissions. This position works closely with Lumen's Government Affairs Directors in multiple states, as well as with policy experts and other regulatory and legislative analysts to support the company's regulatory, legislative, and business objectives. NOTE: Position could be located in Denver, Colorado, Salt Lake City, or possibly a remote location. The Main Responsibilities Represent the company before state public utility commissions in both contested case matters and in rulemaking projects, and as an advocate in other matters; from time to time represent the company before other state administrative agencies and local authorities Act as lead attorney in litigation before state public utility commissions involving complex technical, economic, legal, and policy issues, including (but not limited to) drafting of pleadings, motions, and legal briefs, presenting witnesses and conducting cross examination, and managing litigation-related tasks such as development of discovery requests, production of discovery responses, and development of witness testimony Provide expert legal advice on complex matters regarding telecommunications regulation, including drafting of legal and regulatory analyses and risk assessments Provide ongoing legal support to business units and the internal government affairs team to ensure compliance with both new and existing utility laws and regulations, and proactively monitor regulatory and legal developments that may impact the business of the company Engage with and negotiate with other parties, such as litigants, complainants, business competitors, property owners and managers, other utilities such as railroads, and state and local authorities Draft and edit letters, notices, policy statements, tariff provisions, rulemaking comments, and proposed legislation; may occasionally be required to interpret contracts and other commercial instruments and may draft or edit such documents Work closely with other internal regulatory affairs, legislative affairs, and policy experts to develop proactive strategies for achieving the business objectives of the company What We Look For in a Candidate 6-10 years of relevant legal experience, preferably with experience in state or federal administrative law or litigation related to the regulation and business of telecommunications and information services Excellent writing and oral communication skills Experience drafting relevant documents, particularly legal briefs, rulemaking comments and proposed legislation - including general familiarity with document development via Word and Excel. In-depth knowledge or demonstrated ability to gain knowledge of complex technical and economic concepts related to a network-related industry, preferably involving telecommunications and/or information technology Demonstrated leadership and teamwork skills achieving stated objectives while managing varied projects and a sometimes-heavy workload Demonstrated client relationship skills to continuously coordinate with internal business units and other internal legal groups Demonstrated self-starter requiring minimal supervision with the ability to gain required knowledge of new business and legal developments Experience in a technology-oriented business is highly preferred, experience in a telecommunications business is a plus. Must be a team player. Sound legal and business judgment. Juris Doctor from accredited law school. What to Expect Next Requisition #: 246113 EEO Statement We are committed to providing equal employment opportunities to all persons regardless of race, color, ancestry, citizenship, national origin, religion, veteran status, disability, genetic characteristic or information, age, gender, sexual orientation, gender identity, marital status, family status, pregnancy, or other legally protected status (collectively, "protected statuses"). We do not tolerate unlawful discrimination in any employment decisions, including recruiting, hiring, compensation, promotion, benefits, discipline, termination, job assignments or training. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.
03/16/2021
Full time
About Lumen Lumen is guided by our belief that humanity is at its best when technology advances the way we live and work. With 450,000 route fiber miles serving customers in more than 60 countries, we deliver the fastest, most secure global platform for applications and data to help businesses, government and communities deliver amazing experiences. Learn more about Lumen's network, edge cloud, security and communication and collaboration solutions and our purpose to further human progress through technology at news.lumen.com, LinkedIn: /lumentechnologies, Facebook: /lumentechnologies, and YouTube: /lumentechnologies. The Role The Senior Corporate Counsel reports to an Associate General Counsel - Government Affairs and Public Policy in the company's State Government Affairs organization, serving as Lumen's attorney in matters before various state public utility commissions. This position works closely with Lumen's Government Affairs Directors in multiple states, as well as with policy experts and other regulatory and legislative analysts to support the company's regulatory, legislative, and business objectives. NOTE: Position could be located in Denver, Colorado, Salt Lake City, or possibly a remote location. The Main Responsibilities Represent the company before state public utility commissions in both contested case matters and in rulemaking projects, and as an advocate in other matters; from time to time represent the company before other state administrative agencies and local authorities Act as lead attorney in litigation before state public utility commissions involving complex technical, economic, legal, and policy issues, including (but not limited to) drafting of pleadings, motions, and legal briefs, presenting witnesses and conducting cross examination, and managing litigation-related tasks such as development of discovery requests, production of discovery responses, and development of witness testimony Provide expert legal advice on complex matters regarding telecommunications regulation, including drafting of legal and regulatory analyses and risk assessments Provide ongoing legal support to business units and the internal government affairs team to ensure compliance with both new and existing utility laws and regulations, and proactively monitor regulatory and legal developments that may impact the business of the company Engage with and negotiate with other parties, such as litigants, complainants, business competitors, property owners and managers, other utilities such as railroads, and state and local authorities Draft and edit letters, notices, policy statements, tariff provisions, rulemaking comments, and proposed legislation; may occasionally be required to interpret contracts and other commercial instruments and may draft or edit such documents Work closely with other internal regulatory affairs, legislative affairs, and policy experts to develop proactive strategies for achieving the business objectives of the company What We Look For in a Candidate 6-10 years of relevant legal experience, preferably with experience in state or federal administrative law or litigation related to the regulation and business of telecommunications and information services Excellent writing and oral communication skills Experience drafting relevant documents, particularly legal briefs, rulemaking comments and proposed legislation - including general familiarity with document development via Word and Excel. In-depth knowledge or demonstrated ability to gain knowledge of complex technical and economic concepts related to a network-related industry, preferably involving telecommunications and/or information technology Demonstrated leadership and teamwork skills achieving stated objectives while managing varied projects and a sometimes-heavy workload Demonstrated client relationship skills to continuously coordinate with internal business units and other internal legal groups Demonstrated self-starter requiring minimal supervision with the ability to gain required knowledge of new business and legal developments Experience in a technology-oriented business is highly preferred, experience in a telecommunications business is a plus. Must be a team player. Sound legal and business judgment. Juris Doctor from accredited law school. What to Expect Next Requisition #: 246113 EEO Statement We are committed to providing equal employment opportunities to all persons regardless of race, color, ancestry, citizenship, national origin, religion, veteran status, disability, genetic characteristic or information, age, gender, sexual orientation, gender identity, marital status, family status, pregnancy, or other legally protected status (collectively, "protected statuses"). We do not tolerate unlawful discrimination in any employment decisions, including recruiting, hiring, compensation, promotion, benefits, discipline, termination, job assignments or training. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
The position with the Regulatory and Commercial Law team will provide proactive and collaborative legal support in connection one or more of Regeneron's products and will act as a legal advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The role will counsel our internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues. As an Associate Director, Corporate Counsel, a typical day may include: Providing product support counseling for one or more of Regeneron's products/product candidates from development through commercialization and lifecycle planning Overseeing the review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Serving as a voting legal member on relevant external funding committees and proactively helping to develop and improve vital policies and procedures. Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Providing legal support for our patient assistance programs and market access contracts. Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development. This role might be for you if you: Have outstanding interpersonal and conflict resolution skills Work well independently, while meeting aggressive deadlines and prioritizing multiple matters Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions Have exceptional oral and written communication skills Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron's interests Work effectively and expertly with colleagues & clients in a collaborative environment Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures To be considered for this position, you must possess: A solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. JD with excellent law school credentials; licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. At least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
03/04/2021
Full time
The position with the Regulatory and Commercial Law team will provide proactive and collaborative legal support in connection one or more of Regeneron's products and will act as a legal advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The role will counsel our internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues. As an Associate Director, Corporate Counsel, a typical day may include: Providing product support counseling for one or more of Regeneron's products/product candidates from development through commercialization and lifecycle planning Overseeing the review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Serving as a voting legal member on relevant external funding committees and proactively helping to develop and improve vital policies and procedures. Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Providing legal support for our patient assistance programs and market access contracts. Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development. This role might be for you if you: Have outstanding interpersonal and conflict resolution skills Work well independently, while meeting aggressive deadlines and prioritizing multiple matters Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions Have exceptional oral and written communication skills Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron's interests Work effectively and expertly with colleagues & clients in a collaborative environment Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures To be considered for this position, you must possess: A solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. JD with excellent law school credentials; licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. At least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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: The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions. This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions. Job Responsibilities: Regulatory Operations Duties As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus. Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers. Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions. Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services. Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications. Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues. Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects. Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution. Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts. Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities. Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content. Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer. Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive. Develop and training on archiving process as necessary Lead the development and management of projects as applicable in support of the Regulatory Operations department. Manage and develop junior members of staff. Management Duties Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings. Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate. Manage vendor relationships including required resources, issue resolution and contract negotiation. Qualifications (including knowledge & skills): Minimum education and experience level 10+ years of relevant experience and a BA or BS or 8+years with Master or above Preferred qualifications Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge. Management experience is preferred. Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Experience with archive management Experience with vendor management is a plus Strategic thinking is required, with a focus on process improvement and optimization. Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations. Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations. Familiarity with pharmaceutical development and global Regulatory submissions is required. Organized with systematic approach to prioritization Process orientated to achieve the business objective Ability to learn new technologies quickly
03/01/2021
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: The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions. This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions. Job Responsibilities: Regulatory Operations Duties As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus. Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers. Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions. Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services. Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications. Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues. Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects. Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution. Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts. Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities. Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content. Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer. Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive. Develop and training on archiving process as necessary Lead the development and management of projects as applicable in support of the Regulatory Operations department. Manage and develop junior members of staff. Management Duties Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings. Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate. Manage vendor relationships including required resources, issue resolution and contract negotiation. Qualifications (including knowledge & skills): Minimum education and experience level 10+ years of relevant experience and a BA or BS or 8+years with Master or above Preferred qualifications Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge. Management experience is preferred. Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Experience with archive management Experience with vendor management is a plus Strategic thinking is required, with a focus on process improvement and optimization. Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations. Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations. Familiarity with pharmaceutical development and global Regulatory submissions is required. Organized with systematic approach to prioritization Process orientated to achieve the business objective Ability to learn new technologies quickly
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: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).
03/01/2021
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: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
01/30/2021
Full time
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
Job Summary: Responsible for management of day to day Regulatory Affairs activities for investigational and commercial products. Essential Duties & Responsibilities Responsible for preparation of eCTD documentation for variety of regulatory submissions, most importantly NDA and IND submissions to CDER, CBER or CDRH. Manages advisement of project teams on routine regulatory matters. Ensures compliance to the requirements from U.S. and foreign regulatory agencies. Participates in project team discussions and related activities regarding preclinical and clinical aspects of drug development, and coordinates with CMC regulatory personnel on related items. Represents RA interests in company subteams for planning and strategy discussions. Coordinates regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility. Accepts other specific research, due diligence or other matters as assigned. Non-Essential Duties & Responsibilities: Informs and educates other Supernus colleagues about Regulatory issues as needed. Supervisory Responsibilities: Supervision of Regulatory personnel as assigned. Knowledge & Other Qualifications: B.S. Degree in life science or related field, advanced degree strongly preferred. Minimum of 8 years of direct experience in a pharmaceutical, medical device and/or biotech environment, 10 to 12 years' experience preferred. Experience with regulations/guidelines governing development of pharmaceuticals, biologics and medical devices. Comprehensive knowledge of applicable regulatory law and guidance and experience in application of this knowledge to protect team settings. Prior experience with management of direct reports. Detail oriented with good analytical skills. Strong organizational skills with attention to detail and accuracy. Excellent verbal and written communication skills in English language. Ability to work well under pressure. Ability to handle multiple competing priorities. Regulatory Affairs Certification is desirable but not required. Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF. Experience in compilation of Regulatory submissions using eCTD (electronic common technical documents) preferred. Physical Requirements / Work Environment: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions Other Characteristics: Ability to work independently and as part of a team. Ability to maintain high ethical standards of integrity and quality. Capable of being innovative and dynamic in approach to work. Capable of performing other duties as assigned by management. Authorized to legally work in the United States without visa sponsorship. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law. #CB
01/30/2021
Full time
Job Summary: Responsible for management of day to day Regulatory Affairs activities for investigational and commercial products. Essential Duties & Responsibilities Responsible for preparation of eCTD documentation for variety of regulatory submissions, most importantly NDA and IND submissions to CDER, CBER or CDRH. Manages advisement of project teams on routine regulatory matters. Ensures compliance to the requirements from U.S. and foreign regulatory agencies. Participates in project team discussions and related activities regarding preclinical and clinical aspects of drug development, and coordinates with CMC regulatory personnel on related items. Represents RA interests in company subteams for planning and strategy discussions. Coordinates regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility. Accepts other specific research, due diligence or other matters as assigned. Non-Essential Duties & Responsibilities: Informs and educates other Supernus colleagues about Regulatory issues as needed. Supervisory Responsibilities: Supervision of Regulatory personnel as assigned. Knowledge & Other Qualifications: B.S. Degree in life science or related field, advanced degree strongly preferred. Minimum of 8 years of direct experience in a pharmaceutical, medical device and/or biotech environment, 10 to 12 years' experience preferred. Experience with regulations/guidelines governing development of pharmaceuticals, biologics and medical devices. Comprehensive knowledge of applicable regulatory law and guidance and experience in application of this knowledge to protect team settings. Prior experience with management of direct reports. Detail oriented with good analytical skills. Strong organizational skills with attention to detail and accuracy. Excellent verbal and written communication skills in English language. Ability to work well under pressure. Ability to handle multiple competing priorities. Regulatory Affairs Certification is desirable but not required. Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF. Experience in compilation of Regulatory submissions using eCTD (electronic common technical documents) preferred. Physical Requirements / Work Environment: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions Other Characteristics: Ability to work independently and as part of a team. Ability to maintain high ethical standards of integrity and quality. Capable of being innovative and dynamic in approach to work. Capable of performing other duties as assigned by management. Authorized to legally work in the United States without visa sponsorship. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law. #CB
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Job SUMMARY: Allergan is looking for an experienced business leader with a demonstrated track record of developing high-performing teams, collaborating and influencing across matrixed organizations! The ideal candidate will have an exceptional ability to deeply understand the science and landscape, as well as the business considerations important to developing and implementing customer centric strategies. This role will require a leader who combines executive presence, emotional intelligence and a strong work ethic to develop a best-in-class strategic planning capability within the body contouring franchise. The Executive Director, reports to the Associate Vice President of Marketing, and is responsible for the development, analysis and refinement of the body contouring downstream strategies. The Executive Director, Body Contouring Professional Marketing is responsible for the HCP strategy development and commercialization of one of the most exciting launches in the body contouring industry. Responsibilities include, capital and consumable strategies to drive rapid adoption within the body contouring marketplace, pricing and value proposition strategy and consumer activation strategies to drive growth. A key imperative is to maximize the uptake at launch and ultimate value of the brand. This position works in close collaboration with cross functional groups to ensure a successful launch and growth in the core CoolSculpting business. Including sales, Allergan Data Labs, professional relations, finance, sales training, supply operations and GCD. This position works closely with the body contouring HCP community and will need to build strong relationships and gain product advocacy with KOLs, customers and prospects. Therefore, this individual should be highly collaborative, as they will be working with various internal customers and external partners, as well as getting buy-in from key stakeholders. The ideal candidate will have a solid track-record demonstrating strong business acumen, where s/he has successfully taken ideas from inception to completion. Supervisory responsibility: (if applicable) Lead and manage a team that is accountable for the professional strategies to drive system adoption and consumable growth for the Body Contouring division. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Responsible for leading a comprehensive commercialization plan, developing HCP product positioning, core messages, growth strategy and annual marketing plan. Analyze competitive promotional activity and implement appropriate actions. Reviews and responds to changing market dynamics, as indicated through market analysis, customer interaction and sales input, to ensure achievement of goals by directing activities to a rapidly evolving landscape. Provide ongoing program leadership, supervise vendors and agencies and support field execution. Monitor and accelerate program performance through sales and ROI analysis. Contribute towards achieving brand financial and market share goals, manage promotional budget, deliver quarterly profit targets 40% Drive CoolSculpting commercial programs through a collaborative approach with sales and consumer marketing team (ADL) to develop and execute highly effective commercial impact with customers. These programs should incorporate KOL / advisory board feedback from customers. Responsible for overseeing management of all professional program related education, managing the commercial programs budget and external vendors to ensure efficient use of funds, ROI against set objectives and optimal customer service to our customers. 25% Oversee the development and management of promotional programs and tools: Lead the team to develop promotional tactics and sales tools that support brand strategies for capital equipment and consumable businesses. Collaborate with Regulatory, Medical, Legal, Compliance in development of all promotional pieces and programs. Effectively and collaboratively manage agency partners. Participate as appropriate in meetings with Global Commercial Development, Med Affairs, and International Brand teams. 20% Develops and maintains a customer focus that includes effective working relationships with KOL customers (HCP's and CS Specialists) in conjunction with strategy and campaign development. Provide sales team leadership and training, work with field sales representatives on a regular basis, support field training as needed, attend major conventions and meetings, educational and prospecting programs and events. 15% Qualifications job QUALIFICATIONS (MINIMUM REQUIREMENTS): Requirements: Minimum 15+ years of professional industry experience, including at least 3+ years in managerial positions at a medium-to-large health care company (device, phamra, OTC or FMCG). 5+ years professional/consumer marketing- Medical Device preferred but not mandatory. Knowledge of health care and/or Medical Device industry preferred (not mandatory). Solid knowledge of marketing areas including product positioning, marketing plan development and execution, strategic communications, product launch etc. Successful track record of strategic and tactical marketing. Experience launching Medical Devices preferred. Essential Skills, and Competencies: Proven leadership ability to work effectively and influences through others Financial/budgetary experience Ability to analyze difficult, complex situations, understand the details, and not get lost in them Ability to make difficult decisions, deal quickly and effectively with changes, and confront conflict constructively (strong resolution skills) Excellent communication skills, both oral and written, with an ability to make effective presentations to customers, sales team, and senior management Ability to appropriately prioritize and execute multiple critical issues Strong interpersonal skills, managing multiple stakeholders in a changing and flexible environment Willingness to travel 40% of the time Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/28/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Job SUMMARY: Allergan is looking for an experienced business leader with a demonstrated track record of developing high-performing teams, collaborating and influencing across matrixed organizations! The ideal candidate will have an exceptional ability to deeply understand the science and landscape, as well as the business considerations important to developing and implementing customer centric strategies. This role will require a leader who combines executive presence, emotional intelligence and a strong work ethic to develop a best-in-class strategic planning capability within the body contouring franchise. The Executive Director, reports to the Associate Vice President of Marketing, and is responsible for the development, analysis and refinement of the body contouring downstream strategies. The Executive Director, Body Contouring Professional Marketing is responsible for the HCP strategy development and commercialization of one of the most exciting launches in the body contouring industry. Responsibilities include, capital and consumable strategies to drive rapid adoption within the body contouring marketplace, pricing and value proposition strategy and consumer activation strategies to drive growth. A key imperative is to maximize the uptake at launch and ultimate value of the brand. This position works in close collaboration with cross functional groups to ensure a successful launch and growth in the core CoolSculpting business. Including sales, Allergan Data Labs, professional relations, finance, sales training, supply operations and GCD. This position works closely with the body contouring HCP community and will need to build strong relationships and gain product advocacy with KOLs, customers and prospects. Therefore, this individual should be highly collaborative, as they will be working with various internal customers and external partners, as well as getting buy-in from key stakeholders. The ideal candidate will have a solid track-record demonstrating strong business acumen, where s/he has successfully taken ideas from inception to completion. Supervisory responsibility: (if applicable) Lead and manage a team that is accountable for the professional strategies to drive system adoption and consumable growth for the Body Contouring division. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Responsible for leading a comprehensive commercialization plan, developing HCP product positioning, core messages, growth strategy and annual marketing plan. Analyze competitive promotional activity and implement appropriate actions. Reviews and responds to changing market dynamics, as indicated through market analysis, customer interaction and sales input, to ensure achievement of goals by directing activities to a rapidly evolving landscape. Provide ongoing program leadership, supervise vendors and agencies and support field execution. Monitor and accelerate program performance through sales and ROI analysis. Contribute towards achieving brand financial and market share goals, manage promotional budget, deliver quarterly profit targets 40% Drive CoolSculpting commercial programs through a collaborative approach with sales and consumer marketing team (ADL) to develop and execute highly effective commercial impact with customers. These programs should incorporate KOL / advisory board feedback from customers. Responsible for overseeing management of all professional program related education, managing the commercial programs budget and external vendors to ensure efficient use of funds, ROI against set objectives and optimal customer service to our customers. 25% Oversee the development and management of promotional programs and tools: Lead the team to develop promotional tactics and sales tools that support brand strategies for capital equipment and consumable businesses. Collaborate with Regulatory, Medical, Legal, Compliance in development of all promotional pieces and programs. Effectively and collaboratively manage agency partners. Participate as appropriate in meetings with Global Commercial Development, Med Affairs, and International Brand teams. 20% Develops and maintains a customer focus that includes effective working relationships with KOL customers (HCP's and CS Specialists) in conjunction with strategy and campaign development. Provide sales team leadership and training, work with field sales representatives on a regular basis, support field training as needed, attend major conventions and meetings, educational and prospecting programs and events. 15% Qualifications job QUALIFICATIONS (MINIMUM REQUIREMENTS): Requirements: Minimum 15+ years of professional industry experience, including at least 3+ years in managerial positions at a medium-to-large health care company (device, phamra, OTC or FMCG). 5+ years professional/consumer marketing- Medical Device preferred but not mandatory. Knowledge of health care and/or Medical Device industry preferred (not mandatory). Solid knowledge of marketing areas including product positioning, marketing plan development and execution, strategic communications, product launch etc. Successful track record of strategic and tactical marketing. Experience launching Medical Devices preferred. Essential Skills, and Competencies: Proven leadership ability to work effectively and influences through others Financial/budgetary experience Ability to analyze difficult, complex situations, understand the details, and not get lost in them Ability to make difficult decisions, deal quickly and effectively with changes, and confront conflict constructively (strong resolution skills) Excellent communication skills, both oral and written, with an ability to make effective presentations to customers, sales team, and senior management Ability to appropriately prioritize and execute multiple critical issues Strong interpersonal skills, managing multiple stakeholders in a changing and flexible environment Willingness to travel 40% of the time Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . General Position Summary/Purpose: The Associate Director, Patient Support Programs Marketing - Imbruvica (Market Access) will primarily focus on developing and implementing strategies for supporting current IMBRUVICA patients during their treatment journey. This will include optimizing our current patient support program messaging and materials as well as identifying and implementing additional tactics focused on patient adherence. This individual will be responsible for the communication strategy and management of several marketing initiatives including overall message development, field promotional materials to drive awareness, updates to digital assets such as our websites, and media plans and creative. The Associate Director, Patient Support Programs Marketing - Imbruvica reports into the Director of US Patient Support Programs and sits within the Market Access team. The chosen candidate will have significant interaction with the US commercial teams across both Pharmacyclics and AbbVie, including brand marketing, market access, business analytics, IT, and sales and marketing leadership. This individual must ensure that patient support initiatives are well aligned to the broader brand needs and that the patient support program is well integrated across the broader IMBRUVICA story. Responsibilities: Collaborate with Patient Support Programs and other Market Access Director(s) and business leaders to build, manage and execute marketing plans to achieve patient support objectives and goals including program enrollments and patient edherence.. Drive and participate in business and patient support program planning process. Effectively work, collaborate and drive results through our co-promotion alliance on both strategic alignment and tactical roll-out in a timely fashion. Influence business leaders and effectively collaborate cross-functionally to deliver business results. Develop and review key marketing materials and lead projects through the legal, regulatory, and medical review process. Coordinate the work of multiple external vendors and internal departments including market access, brand marketing, market research, legal, regulatory, medical affairs, corporate compliance, and IT. Collaborate with sales training to ensure effective, impactful, best in class training on patient support tools and programs. Manage and monitor A&P budget and develop metrics to measure programs' success. Champion cross-functional activities at key congresses and tradeshows. Research competitive programs and keep the organization well informed of external initiatives Develop and deliver executive updates for business reviews and new findings. Qualifications Qualifications: Bachelor's Degree required. 7+ Years of relevant experience in developing, executing, and measuring programs for specialty products Proven patient support, patient access and/or patient marketing experience with increased proficiency in all marketing skills Proven ability to collaborate and work cross-functionally to drive business results in a heavily matrixed, fast-paced environment Demonstrated track record of increasing responsibility within sales and marketing Ability to translate strategic vision into tactical action, identify the highest impact ideas and plans and focus efforts by resource allocation Strong leadership and ability to drive influence across stakeholders to set direction, align work efforts, and ensure outstanding execution Outstanding project management skills and experience managing multiple vendors, marketing partners, agency partners and ideally, alliance partners. Strong understanding of legal and regulatory environment in pharmaceutical promotions, pharma industry guidelines, and other compliance-related issues Strong interpersonal skills, excellent oral, written and presentation skills Experience with the management of budgets and vendors Ability to travel approximately 20% of the time Significant Work Activities N/A Travel Yes, 25 % of the Time Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/27/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . General Position Summary/Purpose: The Associate Director, Patient Support Programs Marketing - Imbruvica (Market Access) will primarily focus on developing and implementing strategies for supporting current IMBRUVICA patients during their treatment journey. This will include optimizing our current patient support program messaging and materials as well as identifying and implementing additional tactics focused on patient adherence. This individual will be responsible for the communication strategy and management of several marketing initiatives including overall message development, field promotional materials to drive awareness, updates to digital assets such as our websites, and media plans and creative. The Associate Director, Patient Support Programs Marketing - Imbruvica reports into the Director of US Patient Support Programs and sits within the Market Access team. The chosen candidate will have significant interaction with the US commercial teams across both Pharmacyclics and AbbVie, including brand marketing, market access, business analytics, IT, and sales and marketing leadership. This individual must ensure that patient support initiatives are well aligned to the broader brand needs and that the patient support program is well integrated across the broader IMBRUVICA story. Responsibilities: Collaborate with Patient Support Programs and other Market Access Director(s) and business leaders to build, manage and execute marketing plans to achieve patient support objectives and goals including program enrollments and patient edherence.. Drive and participate in business and patient support program planning process. Effectively work, collaborate and drive results through our co-promotion alliance on both strategic alignment and tactical roll-out in a timely fashion. Influence business leaders and effectively collaborate cross-functionally to deliver business results. Develop and review key marketing materials and lead projects through the legal, regulatory, and medical review process. Coordinate the work of multiple external vendors and internal departments including market access, brand marketing, market research, legal, regulatory, medical affairs, corporate compliance, and IT. Collaborate with sales training to ensure effective, impactful, best in class training on patient support tools and programs. Manage and monitor A&P budget and develop metrics to measure programs' success. Champion cross-functional activities at key congresses and tradeshows. Research competitive programs and keep the organization well informed of external initiatives Develop and deliver executive updates for business reviews and new findings. Qualifications Qualifications: Bachelor's Degree required. 7+ Years of relevant experience in developing, executing, and measuring programs for specialty products Proven patient support, patient access and/or patient marketing experience with increased proficiency in all marketing skills Proven ability to collaborate and work cross-functionally to drive business results in a heavily matrixed, fast-paced environment Demonstrated track record of increasing responsibility within sales and marketing Ability to translate strategic vision into tactical action, identify the highest impact ideas and plans and focus efforts by resource allocation Strong leadership and ability to drive influence across stakeholders to set direction, align work efforts, and ensure outstanding execution Outstanding project management skills and experience managing multiple vendors, marketing partners, agency partners and ideally, alliance partners. Strong understanding of legal and regulatory environment in pharmaceutical promotions, pharma industry guidelines, and other compliance-related issues Strong interpersonal skills, excellent oral, written and presentation skills Experience with the management of budgets and vendors Ability to travel approximately 20% of the time Significant Work Activities N/A Travel Yes, 25 % of the Time Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
The position will support Regeneron's product development lifecycle and will act as a legal advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The incumbent will counsel our internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The role will provide practical and strategic legal advice on a broad range of issues and will directly influence our pipeline of commercial products. As an Associate Director, Corporate Counsel, a typical day may include: Oversight, review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Serving as a voting legal member on relevant external funding committees and proactively helping to develop and improve vital policies and procedures. Review and approval of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Providing product support and / or counseling for one or more Regeneron products/product candidates from development through commercialization and lifecycle planning. Providing legal support for our patient assistance programs and market access contracts. Assisting with healthcare regulatory matters including supervising the enforcement environment, client training, and compliance policy development. This role might be for you if you: Have outstanding interpersonal and conflict resolution skills Work well independently, while meeting aggressive deadlines and prioritizing multiple matters Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions Have exceptional oral and written communication skills Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron's interests Work effectively and expertly with colleagues & clients in a collaborative environment Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures To be considered for this position, you must possess: A solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. JD with excellent law school credentials; licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. At least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
01/27/2021
Full time
The position will support Regeneron's product development lifecycle and will act as a legal advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The incumbent will counsel our internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The role will provide practical and strategic legal advice on a broad range of issues and will directly influence our pipeline of commercial products. As an Associate Director, Corporate Counsel, a typical day may include: Oversight, review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Serving as a voting legal member on relevant external funding committees and proactively helping to develop and improve vital policies and procedures. Review and approval of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Providing product support and / or counseling for one or more Regeneron products/product candidates from development through commercialization and lifecycle planning. Providing legal support for our patient assistance programs and market access contracts. Assisting with healthcare regulatory matters including supervising the enforcement environment, client training, and compliance policy development. This role might be for you if you: Have outstanding interpersonal and conflict resolution skills Work well independently, while meeting aggressive deadlines and prioritizing multiple matters Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions Have exceptional oral and written communication skills Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron's interests Work effectively and expertly with colleagues & clients in a collaborative environment Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures To be considered for this position, you must possess: A solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. JD with excellent law school credentials; licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. At least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The Director, Head of Analytical Sciences and Technology (AS&T) will be part of the CMC Technical Operations leadership team and a key member of the wider CMC organization. The incumbent will work cross functionally to support the successful development and manufacture of Precision BioSciences Cell and Gene Therapy Products. This is a highly visible role within Precision BioSciences as well as with external partners and will be influential in the strategic and tactical leadership of the Technical Operations organization. The Director, Head of AS&T will be responsible for leading the AS&T function in the development and execution of analytical testing strategies to support the manufacture of allogeneic CAR T and AAV gene therapy products. Responsibilities include oversight of analytical testing at external contract laboratories and contract manufacturers, development and implementation of stability strategies for the allogeneic CAR-T, AAV, and mRNA platforms, management of the critical reagent program, and implementation of data analytics approaches for tracking and trending product quality and method performance. The successful candidate will also provide leadership in defining the analytical strategy and development of plans to support late-stage and commercial readiness. The Head of AS&T will work cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Analytical Development functions to establish state of the art and robust analytical approaches that comply with regulatory expectations and relevant quality guidelines. This role will also work closely with the Head of MS&T and the Head of Manufacturing to support implementation of appropriate analytical control strategies for new programs and optimized manufacturing processes. The Head of AS&T will also lead/support establishment of specifications, product comparability studies, and technical investigations. Additionally, the success candidate will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Provide oversight of external testing laboratory activities including management of analytical testing, data review, troubleshooting, method improvement, generation of reports, and technical support; support external technology transfers as needed Develop and implement a GMP-compliant Stability Program for Precision BioSciences Cell and Gene Therapy products, and all associated key process intermediates (cell banks, plasmids, mRNA, AAV) Support or lead the development of analytical control strategies for CAR T and AAV products, and key process intermediates Implement and manage an analytical data tracking and trending program to monitor product quality, stability, and method performance Develop and maintain an effective program to manage Critical Reagents and Reference Standards to ensure compliant and consistent product quality testing Work cross-functionally to define a stage-appropriate control strategy for Infectious Disease Testing (IDT) for allogeneic CAR T products Support development of phase-appropriate method validation approaches for release and characterization testing Support or lead the Specification Team to establish, review, update and maintain product specifications for CAR T and AAV products as well as for key process intermediates Author/Review study protocols, reports, SOPs, investigations, change controls, and method development/qualification reports Author/Review regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities Develop short- and long-term strategic plans for the AS&T function that are aligned with Precisions plans to support development and commercialization of its products Set strategic objectives, provide clear direction, and manage execution for the AS&T function Responsible for organizational design and staffing decisions for the AS&T function. Recruit, retain, train and develop team members Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc. Remain current with regulatory and industry requirements relevant to analytical testing, specifications, and stability programs for cell and gene therapy products to support clinical development and commercial registration Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: PhD in Biochemistry, Biology, or related field and 10+ years of experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality management, or equivalent combination of education and experience 7+ years of analytical management experience to support development of biological products Deep expertise in assay development, method qualification/validation, quality requirements, and regulatory expectations for testing of biological and cell & gene therapy products Experience in authoring regulatory submissions (INDs, briefing packages, BLAs) and face-to-face interactions with regulatory agencies (FDA) Expertise in leading activities to support technical investigations, deviations and change controls Demonstrated experience managing analytical testing at external contract organizations Preferred: Experience in Quality Control, Analytical Sciences and Technology, or Analytical Development in a biopharmaceutical or cell and gene therapy company Experience with gene/cell therapy products; experience with late-stage and commercialization programs strongly preferred Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion Comfortable with rolling up the sleeves and executing the work needed to support the success of projects in a small company environment Strong critical thinking and problem-solving skills Excellent written and verbal communication skills Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses Travel Requirements This position requires some travel (10%) Location This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed. Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
01/23/2021
Full time
The Director, Head of Analytical Sciences and Technology (AS&T) will be part of the CMC Technical Operations leadership team and a key member of the wider CMC organization. The incumbent will work cross functionally to support the successful development and manufacture of Precision BioSciences Cell and Gene Therapy Products. This is a highly visible role within Precision BioSciences as well as with external partners and will be influential in the strategic and tactical leadership of the Technical Operations organization. The Director, Head of AS&T will be responsible for leading the AS&T function in the development and execution of analytical testing strategies to support the manufacture of allogeneic CAR T and AAV gene therapy products. Responsibilities include oversight of analytical testing at external contract laboratories and contract manufacturers, development and implementation of stability strategies for the allogeneic CAR-T, AAV, and mRNA platforms, management of the critical reagent program, and implementation of data analytics approaches for tracking and trending product quality and method performance. The successful candidate will also provide leadership in defining the analytical strategy and development of plans to support late-stage and commercial readiness. The Head of AS&T will work cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Analytical Development functions to establish state of the art and robust analytical approaches that comply with regulatory expectations and relevant quality guidelines. This role will also work closely with the Head of MS&T and the Head of Manufacturing to support implementation of appropriate analytical control strategies for new programs and optimized manufacturing processes. The Head of AS&T will also lead/support establishment of specifications, product comparability studies, and technical investigations. Additionally, the success candidate will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Provide oversight of external testing laboratory activities including management of analytical testing, data review, troubleshooting, method improvement, generation of reports, and technical support; support external technology transfers as needed Develop and implement a GMP-compliant Stability Program for Precision BioSciences Cell and Gene Therapy products, and all associated key process intermediates (cell banks, plasmids, mRNA, AAV) Support or lead the development of analytical control strategies for CAR T and AAV products, and key process intermediates Implement and manage an analytical data tracking and trending program to monitor product quality, stability, and method performance Develop and maintain an effective program to manage Critical Reagents and Reference Standards to ensure compliant and consistent product quality testing Work cross-functionally to define a stage-appropriate control strategy for Infectious Disease Testing (IDT) for allogeneic CAR T products Support development of phase-appropriate method validation approaches for release and characterization testing Support or lead the Specification Team to establish, review, update and maintain product specifications for CAR T and AAV products as well as for key process intermediates Author/Review study protocols, reports, SOPs, investigations, change controls, and method development/qualification reports Author/Review regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities Develop short- and long-term strategic plans for the AS&T function that are aligned with Precisions plans to support development and commercialization of its products Set strategic objectives, provide clear direction, and manage execution for the AS&T function Responsible for organizational design and staffing decisions for the AS&T function. Recruit, retain, train and develop team members Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc. Remain current with regulatory and industry requirements relevant to analytical testing, specifications, and stability programs for cell and gene therapy products to support clinical development and commercial registration Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: PhD in Biochemistry, Biology, or related field and 10+ years of experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality management, or equivalent combination of education and experience 7+ years of analytical management experience to support development of biological products Deep expertise in assay development, method qualification/validation, quality requirements, and regulatory expectations for testing of biological and cell & gene therapy products Experience in authoring regulatory submissions (INDs, briefing packages, BLAs) and face-to-face interactions with regulatory agencies (FDA) Expertise in leading activities to support technical investigations, deviations and change controls Demonstrated experience managing analytical testing at external contract organizations Preferred: Experience in Quality Control, Analytical Sciences and Technology, or Analytical Development in a biopharmaceutical or cell and gene therapy company Experience with gene/cell therapy products; experience with late-stage and commercialization programs strongly preferred Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion Comfortable with rolling up the sleeves and executing the work needed to support the success of projects in a small company environment Strong critical thinking and problem-solving skills Excellent written and verbal communication skills Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses Travel Requirements This position requires some travel (10%) Location This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed. Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Executive Director, Global Medical Brand Lead (GMBL), is a Global Subject Matter Expert who owns the responsibility of this critical asset from the Medical Affairs side, working cross functionally to ensure strategic alignment, Global Medical Brand Plan creation and implementation. Responsibilities Ensures the creation of a consolidated Global Medical Affairs strategy and Plan based on cross functional alignment and an Integrated Plan. Supports regions/countries to ensure the implementation and execution of the agreed upon strategy and tactics Ensures accurate, robust, and appropriate and aligned medical/scientific exchange based on knowledge and clinical expertise with regional/country stakeholders and partner with internal stakeholders in driving success. Works closely with the Commercial Global Brand Lead, Market Access, RWE, R&D and other critical stakeholders. Oversees the strategic plan and implementation of data generation activities, publications, and presentations (whether targeted to specific individuals, institutions, or at congresses) to (1.) ensure the proper capture, interpretation, and analysis of external insights, and (2.) address any scientific decision support needs from inquiries coming into NGTx. Builds the Global Medical Affairs Plan & Strategy based on insight from internal and external stakeholders and in alignment with the company priorities. Works closely with GBL marketing, HEOR, RWE and other commercial stakeholders to create an aligned strategy and plan of action to support the brand. Works closely with R&D and other scientific/Medical functions. Ensures disseminating the Global Medical Strategy and Plan to regions/countries and adapting to local/regional needs. Ensure creation of a clear strategy and action plan to address data gaps. Work closely with the Pub and Comm. team to optimize the data published and disseminating to support the brand strategy. Provides input into regional engagement plans with Key Opinion Leaders (KOLs) and other key external stakeholders aligned with the regional/country Medical Affairs plan. Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines. With the VP of Scientific, strategy acts as the Lead resource to external stakeholders (e.g. caregivers, patients, healthcare professionals) but also internal associates who request information on company products, ensuring accurate and appropriate responses. Captures and provides timely insights on emerging clinical and scientific trends back to the organization. Delivers timely, fair balanced, objective, scientific and economic information and education to health care customers, managed markets/healthcare/payer Actively contributes to the execution of the company's strategy at scientific meetings in support of Regional Medical Director meeting/booth coverage and KOL meetings. Provides medical input into Health Economics and Outcomes Research (HEOR), disease models, epidemiological studies, market research, and real-world study proposals. Travel as needed to the stakeholder groups throughout the regions and countries to proactively execute the above responsibilities and effect the desired outcomes. Other related job duties as assigned. Qualifications Advanced Scientific degree, MD with 8 years of direct experience in Medical Affairs. Specific spinal muscular atrophy (SMA) clinical experience, in either an industry, clinical, or laboratory setting is preferred. Neurology, Neurodegenerative disease and/or pediatric specialty experience, in either an industry, clinical, or laboratory setting. Experience with data analysis, synthesis and presentations. Experience interacting with other providers (HCPs), opinion leaders (KOLs), and researchers (PIs). Experience with Payer organizations preferred. Overall strong ability to understand the disease state, mechanism of action, value proposition - both from an absolute and relative/competitive standpoint - combined with speaking and presentations skills (i.e. gravitas) to ensure trustful and authoritative interactions with all stakeholder sets (KOLs, payers, patients, patient advocacy groups, etc.). 50% - 60% international travel. Comfortable in creating and making presentations Strong interpersonal skills and experience in cross functional matrix environment The level of this position will be based on the final candidate's qualifications. Novartis Gene Therapies Benefit Summary: Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and employee recognition scheme are some of the benefits you will receive as an employee of Novartis Gene Therapies. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
01/20/2021
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Executive Director, Global Medical Brand Lead (GMBL), is a Global Subject Matter Expert who owns the responsibility of this critical asset from the Medical Affairs side, working cross functionally to ensure strategic alignment, Global Medical Brand Plan creation and implementation. Responsibilities Ensures the creation of a consolidated Global Medical Affairs strategy and Plan based on cross functional alignment and an Integrated Plan. Supports regions/countries to ensure the implementation and execution of the agreed upon strategy and tactics Ensures accurate, robust, and appropriate and aligned medical/scientific exchange based on knowledge and clinical expertise with regional/country stakeholders and partner with internal stakeholders in driving success. Works closely with the Commercial Global Brand Lead, Market Access, RWE, R&D and other critical stakeholders. Oversees the strategic plan and implementation of data generation activities, publications, and presentations (whether targeted to specific individuals, institutions, or at congresses) to (1.) ensure the proper capture, interpretation, and analysis of external insights, and (2.) address any scientific decision support needs from inquiries coming into NGTx. Builds the Global Medical Affairs Plan & Strategy based on insight from internal and external stakeholders and in alignment with the company priorities. Works closely with GBL marketing, HEOR, RWE and other commercial stakeholders to create an aligned strategy and plan of action to support the brand. Works closely with R&D and other scientific/Medical functions. Ensures disseminating the Global Medical Strategy and Plan to regions/countries and adapting to local/regional needs. Ensure creation of a clear strategy and action plan to address data gaps. Work closely with the Pub and Comm. team to optimize the data published and disseminating to support the brand strategy. Provides input into regional engagement plans with Key Opinion Leaders (KOLs) and other key external stakeholders aligned with the regional/country Medical Affairs plan. Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines. With the VP of Scientific, strategy acts as the Lead resource to external stakeholders (e.g. caregivers, patients, healthcare professionals) but also internal associates who request information on company products, ensuring accurate and appropriate responses. Captures and provides timely insights on emerging clinical and scientific trends back to the organization. Delivers timely, fair balanced, objective, scientific and economic information and education to health care customers, managed markets/healthcare/payer Actively contributes to the execution of the company's strategy at scientific meetings in support of Regional Medical Director meeting/booth coverage and KOL meetings. Provides medical input into Health Economics and Outcomes Research (HEOR), disease models, epidemiological studies, market research, and real-world study proposals. Travel as needed to the stakeholder groups throughout the regions and countries to proactively execute the above responsibilities and effect the desired outcomes. Other related job duties as assigned. Qualifications Advanced Scientific degree, MD with 8 years of direct experience in Medical Affairs. Specific spinal muscular atrophy (SMA) clinical experience, in either an industry, clinical, or laboratory setting is preferred. Neurology, Neurodegenerative disease and/or pediatric specialty experience, in either an industry, clinical, or laboratory setting. Experience with data analysis, synthesis and presentations. Experience interacting with other providers (HCPs), opinion leaders (KOLs), and researchers (PIs). Experience with Payer organizations preferred. Overall strong ability to understand the disease state, mechanism of action, value proposition - both from an absolute and relative/competitive standpoint - combined with speaking and presentations skills (i.e. gravitas) to ensure trustful and authoritative interactions with all stakeholder sets (KOLs, payers, patients, patient advocacy groups, etc.). 50% - 60% international travel. Comfortable in creating and making presentations Strong interpersonal skills and experience in cross functional matrix environment The level of this position will be based on the final candidate's qualifications. Novartis Gene Therapies Benefit Summary: Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and employee recognition scheme are some of the benefits you will receive as an employee of Novartis Gene Therapies. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
Ipsen Biopharmaceuticals, Inc.
Basking Ridge, New Jersey
Title: Associate Director, Supply Chain And Third Party Logistics Operations Company: Ipsen Biopharmaceuticals Inc. Job Description: The primary objectives of the Associate Director Supply Chain and Third-Party Logistics Operations role are: To be the primary liaison with Global Supply Chain and have functional responsibility for management of the company's domestic and global commercial and clinical inventory management, clinical trial materials, and commercial supply production planning for manufacturing at the affiliate sites in the United States. Responsible for developing a comprehensive understanding of and managing day to day operations at Ipsen's Third-Party Logistics (3PL) provider, ensuring appropriate inventories are viable, managing the daily interaction between 3PL Customer Service and Ipsen, coordinating special needs and special requests to meet patient and customer needs; review and management of daily activities, financial, product, and logistical flows with the primary goal of connecting patients with the product and the secondary goal of supporting Ipsen's needs. The Associate Director Supply Chain and Third-Party Logistics Operations will be responsible for supporting the development of the North America market supply chain solution to ensure adequate inventory is available and supplied for patient use, using data to synthesize information in support of Trade partner activity, and being primarily responsible for heading up the daily relationship between Ipsen and its 3PL provider in all functions related to Trade customer needs, as well as any health care and patient needs that fall under the influence control of the 3PL. Critical to the successful execution of this role and the business relationship management is the ongoing collaboration and involvement of key stakeholders in understanding the validity and confidence of monthly forecasting, sales trends, and marketing initiatives to support the coordination of Supply Chain activities and to validate assumptions about demand forecasts. Furthermore, the incumbent must be comfortable guiding and leading without authority, in particular in working with the 3PL to maintain compliance against expectations and requirements. Essential Functions (Primary duties/responsibilities performed in order of importance, methods used and end result. Indicate % of time spent on each; list no function less than 10%) Function: 3PL relationship and activities management Analyze and understand product demand, flow, inventory, replenishment process, lead times. Interfaces with appropriate Trade personnel, and where appropriate Medical personnel to manage through complex issues and to coordinate special deliverables as needed. Proficient at SAP and other systems to ensure appropriate systems updates and data flows to maintain process current. Supports Medical in training and serving as a backup to procuring and delivering product for investigational purposes. Responsible for working with Data Aggregator and Data Interpreter companies to manage Trade-specific data deliverables that are derived from the 3PL Builds and presents 3PL scorecards measuring performance against contract. Supports Trade Account Directors through business analysis in ensuring product distribution and contractual performance of the 3PL are optimal. Understands and with the support of Account Directors, integrates Trade customer inventory levels of Ipsen products in customer warehouses with the goal of understanding the impact to 3PL inventory, and to Supply Chain orders Supports Sr. Director, Trade in managing requests from Finance relative to product purchasing trends Examines field intelligence data and internally discusses appropriate inventory changes and adjustments at 3PL with Sr. Director, Trade, implementing as needed to meet field activities. Proficient at assisting Trade in resolving customer distribution issues by having a good working knowledge of various 3PL departments and functional roles within those departments. Analyze and recommend process enhancements to shipping and/or packaging needs Responsible for reviewing, approving or denying initial customer returns Responsible for approving Disposition Requests for product destruction. Routinely coordinates with 3PL and Ipsen for destruction of idle inventory to minimize Ipsen inventory carrying costs. Interfaces with Quality and Medical affairs on all clinical shipments Is knowledgeable of customer ordering trends and takes appropriate steps to communicate missing or potential errant orders. Approves PAP shipments Understands the sample fulfillment process and ensures valid sample requests are fulfilled per Ipsen shipping requirements. Interfaces with 3PL and Quality to ensure new product is released in a timely manner. Routinely monitors 3PL warehouse inventories to ensure appropriate inventory ratios for disaster mitigating planning. Frequently interfaces with Ipsen's customer service specialist on all matters related to orders, returns and daily activities. Works proactively with Ipsen's customer service specialist to identify all delayed orders and appropriate action to minimize cost to customer and Ipsen. Provides go/no go shipping directions on all in climate weather impacting Ipsen product and works with Trade and 3PL on contingency plans. Time Allocated: 65% Function: Supply Chain Operations Manage and implement solutions to meet all aspects of the Drug Supply Chain Security Act (DSCSA Effectively review, communicate and submit for approval commercial product replenishment supply plans with Ipsen manufacturing partners as per SLA and contract agreements. Lead monthly S&OP discussions with appropriate decision makers (marketing, sales, finance), coordinating and managing the formal monthly US S&OP demand, supply and reconciliation process as per required time schedules for the affiliate products. Assure alignment between US S&OP practices and Global S&OP parameters / processes. Manage the monthly S&OP Demand Forecasts and inventory positions into the DP / DRP tool. Serve as the supply chain representative on the Commercial Launch, Clinical Operations, and other teams as assigned. Coordinate the planning demands at the Affiliate manufacturing locations via OMC. This responsibility includes establishment and maintenance of rolling forecasts for clinical and commercial products for the Affiliate sites, planning and oversight of clinical packaging and labeling operations for drug product, and coordination of clinical and commercial logistics for product supply. Decide and maintain product inventory balances, replenishment and safety stocks levels as per Global and Local Supply Chain parameters, contracts, trends, and policy, recommending adjustments as necessary to maintain appropriate stocking to meet demand and safety stock Manage and maintain approved freight carriers and brokers sufficient to assure robust transportation and physical handling of all products and materials with special attention on managing cold chain distribution capability and executing robust import / export processes. Develop, input, and review investigational new drug application technical sections of regulatory submissions as related specifically to supply chain packaging, labeling, shipping, and distribution of clinical supplies. Prepare, review and execute all relevant departmental SOP's, business procedures, and work flow processes. Monitor and compare packaging component re-order quantities against supply plan to assure appropriate component inventory levels. Prepare monthly dashboards, KPIs and metrics sufficient to measure performance of warehouse operations, transportation processes, inventory levels, and forecast (demand and supply) accuracy. Execute actions to remediate issues and drive for continual process and performance improvements. Prepare annual Department Operating Budgets. Manage expenses at or below approved budget spending targets. Prepare and manage purchase orders and contracts required to initiate supply chain services and goods. Audit, validate and approve relevant supply chain vendor invoices for accuracy and timely submission for payment. Up to 30% travel Time Allocated: 35% Reporting Relationships/Significant Contacts (Insert or attach organization chart showing manager, peers and subordinates) Marketing- Brand leads and comptrollers Finance- comptrollers, CFO, Accounting, FP&A Value and Access- Trade Management, Corporate Account Management Scope Measures/Decision Making (Quantitative measures which describe the position's impact on the company. (examples -- operating budget, headcount, gross sales, profit, number of vendors, value of contracts). Also, describe the types of decisions this position makes independently. Management of Supply Chain functions to support $300MM organization Management of $3MM Supply Chain budget Management of $121MM 3PL inventory Management of complex and varied vendor and transportation systems to ensure full and timely support of $300MM organization Creation and management of information and analysis systems to support and enhance operations led by five account directors in support of $300MM organization Incumbent is responsible for managing a complex and varied matrix of vendors, internal and external resources..... click apply for full job details
01/19/2021
Full time
Title: Associate Director, Supply Chain And Third Party Logistics Operations Company: Ipsen Biopharmaceuticals Inc. Job Description: The primary objectives of the Associate Director Supply Chain and Third-Party Logistics Operations role are: To be the primary liaison with Global Supply Chain and have functional responsibility for management of the company's domestic and global commercial and clinical inventory management, clinical trial materials, and commercial supply production planning for manufacturing at the affiliate sites in the United States. Responsible for developing a comprehensive understanding of and managing day to day operations at Ipsen's Third-Party Logistics (3PL) provider, ensuring appropriate inventories are viable, managing the daily interaction between 3PL Customer Service and Ipsen, coordinating special needs and special requests to meet patient and customer needs; review and management of daily activities, financial, product, and logistical flows with the primary goal of connecting patients with the product and the secondary goal of supporting Ipsen's needs. The Associate Director Supply Chain and Third-Party Logistics Operations will be responsible for supporting the development of the North America market supply chain solution to ensure adequate inventory is available and supplied for patient use, using data to synthesize information in support of Trade partner activity, and being primarily responsible for heading up the daily relationship between Ipsen and its 3PL provider in all functions related to Trade customer needs, as well as any health care and patient needs that fall under the influence control of the 3PL. Critical to the successful execution of this role and the business relationship management is the ongoing collaboration and involvement of key stakeholders in understanding the validity and confidence of monthly forecasting, sales trends, and marketing initiatives to support the coordination of Supply Chain activities and to validate assumptions about demand forecasts. Furthermore, the incumbent must be comfortable guiding and leading without authority, in particular in working with the 3PL to maintain compliance against expectations and requirements. Essential Functions (Primary duties/responsibilities performed in order of importance, methods used and end result. Indicate % of time spent on each; list no function less than 10%) Function: 3PL relationship and activities management Analyze and understand product demand, flow, inventory, replenishment process, lead times. Interfaces with appropriate Trade personnel, and where appropriate Medical personnel to manage through complex issues and to coordinate special deliverables as needed. Proficient at SAP and other systems to ensure appropriate systems updates and data flows to maintain process current. Supports Medical in training and serving as a backup to procuring and delivering product for investigational purposes. Responsible for working with Data Aggregator and Data Interpreter companies to manage Trade-specific data deliverables that are derived from the 3PL Builds and presents 3PL scorecards measuring performance against contract. Supports Trade Account Directors through business analysis in ensuring product distribution and contractual performance of the 3PL are optimal. Understands and with the support of Account Directors, integrates Trade customer inventory levels of Ipsen products in customer warehouses with the goal of understanding the impact to 3PL inventory, and to Supply Chain orders Supports Sr. Director, Trade in managing requests from Finance relative to product purchasing trends Examines field intelligence data and internally discusses appropriate inventory changes and adjustments at 3PL with Sr. Director, Trade, implementing as needed to meet field activities. Proficient at assisting Trade in resolving customer distribution issues by having a good working knowledge of various 3PL departments and functional roles within those departments. Analyze and recommend process enhancements to shipping and/or packaging needs Responsible for reviewing, approving or denying initial customer returns Responsible for approving Disposition Requests for product destruction. Routinely coordinates with 3PL and Ipsen for destruction of idle inventory to minimize Ipsen inventory carrying costs. Interfaces with Quality and Medical affairs on all clinical shipments Is knowledgeable of customer ordering trends and takes appropriate steps to communicate missing or potential errant orders. Approves PAP shipments Understands the sample fulfillment process and ensures valid sample requests are fulfilled per Ipsen shipping requirements. Interfaces with 3PL and Quality to ensure new product is released in a timely manner. Routinely monitors 3PL warehouse inventories to ensure appropriate inventory ratios for disaster mitigating planning. Frequently interfaces with Ipsen's customer service specialist on all matters related to orders, returns and daily activities. Works proactively with Ipsen's customer service specialist to identify all delayed orders and appropriate action to minimize cost to customer and Ipsen. Provides go/no go shipping directions on all in climate weather impacting Ipsen product and works with Trade and 3PL on contingency plans. Time Allocated: 65% Function: Supply Chain Operations Manage and implement solutions to meet all aspects of the Drug Supply Chain Security Act (DSCSA Effectively review, communicate and submit for approval commercial product replenishment supply plans with Ipsen manufacturing partners as per SLA and contract agreements. Lead monthly S&OP discussions with appropriate decision makers (marketing, sales, finance), coordinating and managing the formal monthly US S&OP demand, supply and reconciliation process as per required time schedules for the affiliate products. Assure alignment between US S&OP practices and Global S&OP parameters / processes. Manage the monthly S&OP Demand Forecasts and inventory positions into the DP / DRP tool. Serve as the supply chain representative on the Commercial Launch, Clinical Operations, and other teams as assigned. Coordinate the planning demands at the Affiliate manufacturing locations via OMC. This responsibility includes establishment and maintenance of rolling forecasts for clinical and commercial products for the Affiliate sites, planning and oversight of clinical packaging and labeling operations for drug product, and coordination of clinical and commercial logistics for product supply. Decide and maintain product inventory balances, replenishment and safety stocks levels as per Global and Local Supply Chain parameters, contracts, trends, and policy, recommending adjustments as necessary to maintain appropriate stocking to meet demand and safety stock Manage and maintain approved freight carriers and brokers sufficient to assure robust transportation and physical handling of all products and materials with special attention on managing cold chain distribution capability and executing robust import / export processes. Develop, input, and review investigational new drug application technical sections of regulatory submissions as related specifically to supply chain packaging, labeling, shipping, and distribution of clinical supplies. Prepare, review and execute all relevant departmental SOP's, business procedures, and work flow processes. Monitor and compare packaging component re-order quantities against supply plan to assure appropriate component inventory levels. Prepare monthly dashboards, KPIs and metrics sufficient to measure performance of warehouse operations, transportation processes, inventory levels, and forecast (demand and supply) accuracy. Execute actions to remediate issues and drive for continual process and performance improvements. Prepare annual Department Operating Budgets. Manage expenses at or below approved budget spending targets. Prepare and manage purchase orders and contracts required to initiate supply chain services and goods. Audit, validate and approve relevant supply chain vendor invoices for accuracy and timely submission for payment. Up to 30% travel Time Allocated: 35% Reporting Relationships/Significant Contacts (Insert or attach organization chart showing manager, peers and subordinates) Marketing- Brand leads and comptrollers Finance- comptrollers, CFO, Accounting, FP&A Value and Access- Trade Management, Corporate Account Management Scope Measures/Decision Making (Quantitative measures which describe the position's impact on the company. (examples -- operating budget, headcount, gross sales, profit, number of vendors, value of contracts). Also, describe the types of decisions this position makes independently. Management of Supply Chain functions to support $300MM organization Management of $3MM Supply Chain budget Management of $121MM 3PL inventory Management of complex and varied vendor and transportation systems to ensure full and timely support of $300MM organization Creation and management of information and analysis systems to support and enhance operations led by five account directors in support of $300MM organization Incumbent is responsible for managing a complex and varied matrix of vendors, internal and external resources..... click apply for full job details
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Business Ethics Monitoring Associate Director, North America Company: Ipsen Bioscience, Inc. Job Description: As the Business Ethics Monitoring Associate Director, you will be responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. You will provide compliance advice and support to the company, its subsidiaries and affiliates, perform a variety of investigations, and follow-up on others, through resolution. You enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. Your role will involve: Developing and implementing the monitoring program, with trend reporting on identified risks Leading US Business Ethics Monitoring program across all business units Liaising with Global Business Ethics Monitoring to align on program objectives and share best practices Performing live and transactional monitoring across three business units, as well as Medical Affairs and V&A activities. Reporting monitoring results to business unit heads and other functional senior leaders to inform them of the findings, and work to address and remediate such findings through corrective and preventative action plans. Advising and supporting business units and functional teams in the determination of remediation/CAPAs, their implementation and follow-up Documenting and supporting the implementation of remediation/CAPAs to any monitoring findings Leading US Third Party Due Diligence Program by working with the entire US organization Liaising with Global 3rd Party Compliance Program lead to align on program objectives and share best practices Overseeing implementation of compliance recommendations, including those that result from due diligence findings Leading US compliance investigations with significant remediation efforts to resolution Leading risk assessments, working with the Global Risk team and internal audit to review program compliance, and utilizing analytics to monitor it, identifying areas of risk and prioritize risk mitigation Participating in the US Grants and Charitable Donations Committee as a voting member Leading on implementation of compliance recommendations and documentation/records for commercial programs and initiatives Preparing dispute resolution procedures and advising on process Leading training initiatives, and developing the respective materials within areas of responsibility Creating guidelines and tools, and advising different cross-functional teams to ensure compliance Assisting with other compliance work as needed (may involve international matters) In return, you will bring: Bachelor's degree in related discipline Advanced degree preferred - JD or Graduate Degree 5+ Years Pharmaceutical industry experience required 7+ years of Compliance experience A history that shows an increase in responsibility and complexity (progression in responsibility and level) A demonstrated aptitude and knowledge of the life sciences business model & commercial organization If this sounds like an exciting opportunity to apply your pharmaceutical industry experience in our Global Business Ethics department, apply today! IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.","datePosted":"2020-09-18T00:00:00.000Z
01/16/2021
Full time
Title: Business Ethics Monitoring Associate Director, North America Company: Ipsen Bioscience, Inc. Job Description: As the Business Ethics Monitoring Associate Director, you will be responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. You will provide compliance advice and support to the company, its subsidiaries and affiliates, perform a variety of investigations, and follow-up on others, through resolution. You enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. Your role will involve: Developing and implementing the monitoring program, with trend reporting on identified risks Leading US Business Ethics Monitoring program across all business units Liaising with Global Business Ethics Monitoring to align on program objectives and share best practices Performing live and transactional monitoring across three business units, as well as Medical Affairs and V&A activities. Reporting monitoring results to business unit heads and other functional senior leaders to inform them of the findings, and work to address and remediate such findings through corrective and preventative action plans. Advising and supporting business units and functional teams in the determination of remediation/CAPAs, their implementation and follow-up Documenting and supporting the implementation of remediation/CAPAs to any monitoring findings Leading US Third Party Due Diligence Program by working with the entire US organization Liaising with Global 3rd Party Compliance Program lead to align on program objectives and share best practices Overseeing implementation of compliance recommendations, including those that result from due diligence findings Leading US compliance investigations with significant remediation efforts to resolution Leading risk assessments, working with the Global Risk team and internal audit to review program compliance, and utilizing analytics to monitor it, identifying areas of risk and prioritize risk mitigation Participating in the US Grants and Charitable Donations Committee as a voting member Leading on implementation of compliance recommendations and documentation/records for commercial programs and initiatives Preparing dispute resolution procedures and advising on process Leading training initiatives, and developing the respective materials within areas of responsibility Creating guidelines and tools, and advising different cross-functional teams to ensure compliance Assisting with other compliance work as needed (may involve international matters) In return, you will bring: Bachelor's degree in related discipline Advanced degree preferred - JD or Graduate Degree 5+ Years Pharmaceutical industry experience required 7+ years of Compliance experience A history that shows an increase in responsibility and complexity (progression in responsibility and level) A demonstrated aptitude and knowledge of the life sciences business model & commercial organization If this sounds like an exciting opportunity to apply your pharmaceutical industry experience in our Global Business Ethics department, apply today! IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.","datePosted":"2020-09-18T00:00:00.000Z