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
Accountable for staff management and resource allocations in Global Patient Safety, supporting the establishment of a highly effective global safety organization in full compliance with worldwide regulations. Leads safety analysis and global safety teams and participates as a core member of cross-functional groups to ensure the safety profile and product-related decisions for the Hematology-Oncology portfolio.
Responsibilities
- Validate safety signals and lead safety signal assessments
- Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
- 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 and risk management
- Regulatory filing and safety documentation
- Cross-functional collaboration and leadership
- Evidence generation and clinical study support
Education
- MD or DO degree from an accredited medical school
- Residency in medical or surgical specialty
Additional Requirements
- None specified beyond qualifications