Global Safety Medical Director, Rare Disease
Amgen
Summary
Serve as the strategic safety leader for assigned Rare Disease assets within Amgen's global development organization, 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).
Job description
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.
- Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams.
- Support regulatory inspections and inspection readiness activities.
- Domestic and international travel up to 10%.
Basic Qualifications
- MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Relevant clinical experience in an academic, hospital-based, or private practice setting.
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.
- 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.
Requirements
- MD or DO degree from an accredited medical school
- Completion of an accredited medical or surgical residency OR relevant clinical experience in an academic, hospital-based, or private practice setting
- 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
- 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
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Paid Time Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.