Global Safety Exec Medical Director, Safety/CMC - ...

Education: MD degree Must have the ability to travel. Preferred Qualifications: - MD/Ph.D in a biotech-related field (e.g., protein chemistry, molecular biology, pharmacology, toxicology) - Experience with biotech manufacturing and drug safety assessments - Medical device experience - Working knowledge of manufacturing operations and quality systems - Working knowledge of pharm/tox relationships to quality attributes - Working knowledge of risk management processes - Familiarity with forensic investigation practices. The Global Safety Executive Medical Director will provide close medical/safety support to Operations for both product development and commercialization, and will create and maintain a strong cooperative working relationship with both Operations and Safety. The role of developing and maintaining medical/safety subject matter expertise for Operations will be complementary to the role of operations/quality advisor for Safety. Responsiblities include, but are not limited to: - Advise the Quality organization with medical/safety assessments related to non-conformances, product complaints and adverse events - Advise the Quality organization with medical/safety assessments, health hazard evaluation (HHE) related to product actions - Identify quality attributes that may contribute to safety signals - Provide medical/safety assessments for specification changes and specification platforms - Contribute to risk assessments for Operations - Advise and seek input from Safety for quality-related incidents - Develop complex solutions to problems through in-depth analysis, coordination and negotiation with key decision makers - Adapt and integrate own experience with Amgen-wide strategy - Provide expert advice to Sr. Management related to medical/safety issues (product actions) - Support and advise generic and follow-on biologic work streams This position may have direct reports, but will work as an individual contributor 50% of the time. Approximately 20-30% travel.