Senior Medical Director, Global Safety- Obesity and related conditions
Amgen
5 hours ago
Remote friendly (United States)
United States
Medical Affairs
Senior Medical Director, Global Safety
Responsibilities:
- Establish the strategy, direction, and priorities of global safety activities; accountable for the overall safety profile and product-related decisions and deliverables for assigned products.
- Serve as safety expert for assigned product(s) and set pharmacovigilance strategy for obesity and related conditions, including safety strategy insight, medical assessment of safety concerns, and competitive obesity landscape/safety data (e.g., competitive labels, publications, AERS/FAERS).
- Accountable for Amgen’s position on safety concerns unique to the obesity franchise; present positions to senior leadership.
- Manage Safety Directors, Associate Safety Directors, and/or Global Safety Professionals.
- Provide strategic oversight, direction, and authorship for major regulatory safety submissions/responses and deliverables (e.g., safety sections of NDAs, RMPs, PSURs, PBRERs, DSURs, DILs).
- Develop and maintain core datasheet and core reference safety information (e.g., DCSI, core safety information portions of CDS).
- Lead safety strategy and Benefit/Risk Management Process for assigned asset(s) across all indications (including preclinical, FIH, Ph1-3, and post-approval studies).
- Contribute to clinical trial design discussions and develop core clinical trial documents (e.g., ICF, Protocol, Investigator Brochure).
- Provide strategic input as safety representative to cross-functional meetings for evidence generation, data review, and regulatory documents/responses.
- Independently author concise presentations summarizing franchise safety concerns with supporting obesity literature/competitive data and mitigation strategies.
- Chair or participate in safety governance meetings per SOPs/manuals.
- Lead and contribute to process improvement projects as needed.
- Act as delegate for the Therapeutic Area Head (TAH) as needed.
Basic Qualifications:
- Doctorate degree + 5 years of Global Drug Safety experience
OR Master’s degree + 9 years of Global Drug Safety experience
OR Bachelor’s degree + 11 years of Global Drug Safety experience
- At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation/resources (managerial experience may run concurrently).
Preferred Qualifications:
- Fluent knowledge of the Obesity and related condition landscape.
- Medical Doctorate and board certification.
- Adaptable to varied matrix environments with fast turnaround for key deliverables.
- Capable of working under high-pressure environments.
- Experience in people management.
Benefits (Total Rewards Plan; eligibility-based):
- Employee benefits package (Retirement & Savings Plan with company contributions, medical/dental/vision, life/disability, flexible spending accounts)
- Discretionary annual bonus (or sales-based incentive for field sales)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
Application Instructions:
- Apply now; Amgen does not have an application deadline and will continue accepting applications until a sufficient number are received or a candidate is selected.
Responsibilities:
- Establish the strategy, direction, and priorities of global safety activities; accountable for the overall safety profile and product-related decisions and deliverables for assigned products.
- Serve as safety expert for assigned product(s) and set pharmacovigilance strategy for obesity and related conditions, including safety strategy insight, medical assessment of safety concerns, and competitive obesity landscape/safety data (e.g., competitive labels, publications, AERS/FAERS).
- Accountable for Amgen’s position on safety concerns unique to the obesity franchise; present positions to senior leadership.
- Manage Safety Directors, Associate Safety Directors, and/or Global Safety Professionals.
- Provide strategic oversight, direction, and authorship for major regulatory safety submissions/responses and deliverables (e.g., safety sections of NDAs, RMPs, PSURs, PBRERs, DSURs, DILs).
- Develop and maintain core datasheet and core reference safety information (e.g., DCSI, core safety information portions of CDS).
- Lead safety strategy and Benefit/Risk Management Process for assigned asset(s) across all indications (including preclinical, FIH, Ph1-3, and post-approval studies).
- Contribute to clinical trial design discussions and develop core clinical trial documents (e.g., ICF, Protocol, Investigator Brochure).
- Provide strategic input as safety representative to cross-functional meetings for evidence generation, data review, and regulatory documents/responses.
- Independently author concise presentations summarizing franchise safety concerns with supporting obesity literature/competitive data and mitigation strategies.
- Chair or participate in safety governance meetings per SOPs/manuals.
- Lead and contribute to process improvement projects as needed.
- Act as delegate for the Therapeutic Area Head (TAH) as needed.
Basic Qualifications:
- Doctorate degree + 5 years of Global Drug Safety experience
OR Master’s degree + 9 years of Global Drug Safety experience
OR Bachelor’s degree + 11 years of Global Drug Safety experience
- At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation/resources (managerial experience may run concurrently).
Preferred Qualifications:
- Fluent knowledge of the Obesity and related condition landscape.
- Medical Doctorate and board certification.
- Adaptable to varied matrix environments with fast turnaround for key deliverables.
- Capable of working under high-pressure environments.
- Experience in people management.
Benefits (Total Rewards Plan; eligibility-based):
- Employee benefits package (Retirement & Savings Plan with company contributions, medical/dental/vision, life/disability, flexible spending accounts)
- Discretionary annual bonus (or sales-based incentive for field sales)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
Application Instructions:
- Apply now; Amgen does not have an application deadline and will continue accepting applications until a sufficient number are received or a candidate is selected.