Amgen
Global Safety Medical Director, Rare Disease
About this role
Career Category SafetyJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Officer, Medical Director, Rare Disease What you will do Let’s do this. Let’s change the world.In this vital role, you will serve as the strategic safety leader for assigned Rare Disease assets within Amgen's global development organization. You will be accountable for 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). This role is ideal for a physician who has served as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety leader for development-stage assets and has directly influenced key clinical development decisions through safety leadership. The successful candidate will bring expertise in Rare Disease drug development and ideally experience within inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications. You will establish the strategy, direction, and priorities of pharmacovigilance activities and will be accountable for the overall safety profile and safety-related decisions for assigned products. You will lead the Safety Analysis Team (SAT), Global Safety Team (GST), and serve as a core member of the Executive Safety Committee (ESC). You will partner closely with Clinical Development, Translational Medicine, Regulatory, Biostatistics, and Medical Affairs to influence development strategy and support innovative therapies for patients with rare diseases and high unmet medical need.
Responsibilities
- Serve as the accountable physician safety leader for assigned Rare Disease development programs.
- Lead global safety strategy for clinical development programs with a primary focus on Phase 1b and Phase 2 studies.
- 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), 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.
Preferred Qualifications
- 8+ years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development.
- Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety role.
- Significant experience supporting Phase 1b and Phase 2 clinical development programs.
- Experience in Early Clinical Development, including First-in-Human, dose escalation, cohort expansion, proof-of-concept, and translational medicine programs.
- 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 Rare Disease clinical development programs strongly preferred.
- Expertise in inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications strongly preferred.
- Experience supporting biologics, monoclonal antibodies, gene therapies, or other innovative modalities in clinical development preferred.