Global Safety Medical Director - Hematology/Oncology
Amgen
Full-time
Remote friendly (United States)
United States
Medical Affairs
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Role Summary
Global Safety Medical Director - Hematology/Oncology. Lead safety strategy and staff in Global Patient Safety, ensuring full regulatory compliance for the Hematology-Oncology portfolio.
Responsibilities
- Validate safety signals and lead safety signal assessments
- Develop and maintain Core Safety Information
- Prepare/review core and regional risk management plans including additional risk minimization measures
- Prepare/review safety sections of periodic aggregate reports
- Provide safety input to protocols, statistical analysis plans, and clinical study reports
- Prepare/review safety sections of new drug applications and other regulatory filings
- Serve as safety expert on Evidence Generation Team for assigned products
- Inspection Readiness
Qualifications
- Basic Qualifications:
- MD or DO degree from an accredited medical school
- AND
- Completion of an accredited medical or surgical residency
- OR
- Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Preferred Qualifications:
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Previous management and/or mentoring experience
- Experience in the study/research and/or treatment of Oncology disease states
Skills
- Safety signal assessment
- Risk management planning
- Regulatory submissions (safety sections)
- Cross-functional collaboration (Evidence Generation Team, ESC, GST, SAT)
- Inspection readiness
Education
- Medical degree (MD or DO) from an accredited medical school; residency completed