Global Safety Medical Director
Amgen is seeking a Global Safety Medical Director at its main headquarters in Thousand Oaks, CA to join Global Patient Safety (GPS) organization and will report to the Executive Medical Director Global Safety.
The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
The Global Safety Officer (GSO) serves 2 roles:
1) Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
2) The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). These are cross group collaboration teams. The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Physicians.
- 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
- Travel: Domestic and International travel up to 10% may be essential
MD or DO degree from an accredited medical school
Completion of an accredited medical or surgical residency
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting.
- 2 years of industry PV experience
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Previous management and/or mentoring experience
- Experience with hematology/oncology products
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.