Global Safety Senior Medical Director, Obesity - US Remote
Amgen
- USA
- Permanent
- Full-time
- Serve as the safety expert of the assigned product(s) and or setting the strategy, direction, and priorities of pharmacovigilance activities.
- Manage Medical Directors, Associate Med Directors, and/or Global Safety Physicians (GSP).
- Accountable for providing strategic oversight, direction for all major regulatory safety responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs.
- Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS])
- Lead the safety strategy and Benefit/Risk Management Process for assigned portfolio.
- Contribute to the strategic discussion on clinical trial design and developing core clinical trial related documents including but not limited to Informed Consent (ICF), Protocol, and Investigator Brochure (IB)
- Safety representative to cross functional meetings in providing strategic input.
- Act as Chair or participate in safety governance meetings per Standard Operating Procedures and Manuals for assigned products.
- Lead and contribute to functional projects for process improvement as needed.
- Can act as delegate for the TAH (Therapeutic Area Head) as needed.
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible