Global Safety Medical Director, Rare Disease

About the role

Amgen is looking for a physician to serve as the strategic safety leader for assigned Rare Disease assets within its global development organization. The role covers the overall benefit-risk profile, safety strategy, signal management and safety governance of clinical programs, with a primary focus on early clinical development (Phase 1b and Phase 2 studies). It suits a physician who has previously led safety for development-stage assets and influenced key clinical development decisions.

Key responsibilities

• Establish the strategy, direction and priorities of pharmacovigilance activities and own the safety profile and safety-related decisions for assigned products.
• Lead the Safety Analysis Team (SAT), Global Safety Team (GST) and take part in the Executive Safety Committee (ESC).
• Partner with Clinical Development, Translational Medicine, Regulatory, Biostatistics and Medical Affairs to shape development strategy.
• Review and interpret emerging safety data, validate safety signals and lead signal detection, assessment and risk evaluation.
• Develop and maintain Core Safety Information, including Core Data Sheets and informed consent safety language.
• Prepare and review Risk Management Plans, risk minimization strategies and aggregate safety reports.
• Contribute to protocol development, CRF design, statistical analysis plans, clinical study reports and safety monitoring plans.
• Prepare and review safety sections of regulatory submissions (INDs, CTAs, BLAs, NDAs) and act as safety representative on Evidence Generation Teams.
• Support regulatory inspections and inspection readiness; domestic and international travel up to 10%.

Required profile

• MD or DO degree from an accredited medical school, plus completion of an accredited medical or surgical residency, or relevant clinical experience in an academic, hospital-based or private practice setting.
• Preferred: 8+ years of pharmaceutical industry experience in drug safety, clinical safety, pharmacovigilance or clinical development.
• Preferred: experience as a Global Safety Officer, Clinical Safety Lead or equivalent, and significant experience supporting Phase 1b and Phase 2 programs.
• Experience in early clinical development (first-in-human, dose escalation, cohort expansion, proof-of-concept) and regulatory submissions strongly preferred.
• Experience in Rare Disease programs and in inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic or genetic indications strongly preferred.
• Demonstrated leadership in cross-functional matrix organizations; experience with both clinical development and post-marketing safety preferred.

Required skills

• Signal detection, assessment, benefit-risk evaluation and risk management.
• Safety governance and regulatory submission support (INDs, CTAs, BLAs, NDAs).
• Preferred: biologics, monoclonal antibodies, gene therapies and other innovative modalities.

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico), varying by skills, experience and qualifications.
• Total rewards including health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and a flexible spending account.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and time-off plans.
• Flexible work models, including remote and hybrid arrangements where possible.