Global Safety Medical Director
About The Position
The Global Safety Medical Director serves as the strategic safety leader for assigned Obesity and related conditions development programs within Amgen’s global development organization. The role is accountable for the programs’ overall benefit-risk profile, safety strategy, signal management, safety governance, and safety-related decisions. The position establishes the strategy, direction, and priorities of pharmacovigilance activities and provides medical safety leadership throughout clinical development. The Director leads the Safety Analysis Team (SAT) and Global Safety Team (GST), and serves as a core member of the Executive Safety Committee (ESC). The role works closely with Clinical Development, Translational Medicine, Regulatory, Biostatistics, Medical Affairs, and other cross-functional teams to inform development strategy and support therapies for patients with high unmet medical need. Domestic and international travel may be up to 10%.
Requirements
- MD or DO degree from an accredited medical school.
- At least 2 years of clinical research experience and/or basic science research.
- Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety leader for development-stage assets.
- Direct experience influencing clinical development through protocol development, CRF design, safety monitoring plans, dose-escalation decisions, and benefit-risk assessments.
- Expertise in signal detection, signal assessment, benefit-risk evaluation, risk management, and safety governance.
- Experience supporting regulatory submissions and interactions with health authorities, including INDs, CTAs, BLAs, NDAs, MAAs, and responses to regulatory questions.
- Experience presenting safety assessments and recommendations to governance committees, development teams, and regulatory authorities.
- Demonstrated leadership in cross-functional matrix organizations, with the ability to influence development strategy and drive decision-making.
Nice To Haves
- Four or more years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development.
- Experience supporting Obesity clinical development programs.
- Experience with both clinical development and post-marketing safety activities.
Responsibilities
- Serve as the accountable physician safety leader for assigned Obesity development programs.
- Lead global safety strategy for clinical development programs.
- Partner with Clinical Development and Translational Medicine teams to inform dose-escalation, cohort expansion, proof-of-concept, and development decisions.
- Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development.
- Review and interpret emerging safety data and communicate safety implications to development teams and governance committees.
- Lead the Safety Analysis Team (SAT) and Global Safety Team (GST), and participate in Executive Safety Committee (ESC) discussions.
- Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.
- Validate safety signals and lead signal detection, assessment, and risk evaluation activities.
- Develop and maintain Core Safety Information, including Core Data Sheets and informed consent safety language.
- Prepare and review Risk Management Plans (RMPs), risk minimization strategies, and aggregate safety reports.
- Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans.
- Prepare and review safety sections of regulatory submissions, including INDs, CTAs, BLAs, NDAs, and other global submissions.
- Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams.
- Support regulatory inspections and inspection-readiness activities.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and savings plan with company contributions.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
