Global Safety Medical Director
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Job Description
Global Safety Medical Director guiding safety strategy for Amgen’s obesity medicines. Leading pharmacovigilance, benefit-risk evaluation, and clinical development governance.
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 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
- Partner with Clinical Development, Translational Medicine, Regulatory, Biostatistics, and Medical Affairs to influence development strategy and support innovative therapies
Requirements:
- MD or DO degree from an accredited medical school
- 2 years of clinical research experience and/or basic science research
- 4+ years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development preferred
- Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety role
- 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
- Experience supporting Obesity clinical development programs strongly preferred
- Demonstrated leadership in cross-functional matrix organizations with the ability to influence development strategy and drive decision-making
- Experience with both clinical development and post-marketing safety activities preferred
- Willingness to undertake domestic and international travel up to 10%
Benefits:
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Financial plans with opportunities to save towards retirement or other goals
- Career development opportunities
- Work/life balance
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