Amgen is looking for a Global Safety Medical Director to establish a highly effective global safety organization for our General Medicine therapeutic area. You will be accountable for full compliance with worldwide regulations while overseeing the safety profile of marketed products, biosimilar development, and early pipeline initiatives, primarily in Cardio-Metabolic diseases.
What You'll Do
- Validate safety signals and lead safety signal assessments
- Develop and maintain Core Safety Information including core data sheets and core risks in informed consent forms
- Prepare and review core and regional risk management plans, including additional risk minimization measures
- Prepare and review safety sections of periodic aggregate reports
- Provide safety input to protocols, statistical analysis plans, and clinical study reports
- Prepare and review safety sections of new drug applications and other regulatory filings
- Serve as safety lead on Evidence Generation Team for assigned products
- Support inspection readiness activities
What We're Looking For
- MD or DO degree from an accredited medical school
- Completion of an accredited medical or surgical residency OR clinical experience in an accredited academic setting or private practice, including hospital-based settings
Nice to Have
- Industry pharmacovigilance experience
- Product safety experience within the bio/pharmaceutical industry or a regulatory agency
- Previous management or mentoring experience
- Board certification or equivalent training
- Leadership experience managing the safety profile of assigned products with cross-functional teams
Benefits & Compensation
- Compensation range: $272,481 - $341,319 USD
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
Amgen fosters an award-winning, collaborative, and science-based culture. Our shared mission—to serve patients living with serious illnesses—drives all that we do. We maintain an inclusive environment of diverse, ethical, committed, and highly accomplished people.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
