Global Safety Senior Director, PV – Obesity
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Job Description
Global Safety Senior Director at Amgen overseeing regulatory safety submissions and leading safety strategy for product portfolios. Ensuring compliance and providing staff training in a collaborative environment.
Responsibilities:
- Provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables
- Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio
- Chairs or participates in safety governance meetings per Standard Operating Procedures and Manuals
- Accountable for the Development and maintenance of core reference safety information
- Analyze safety data from clinical studies and contribute to core safety messages and conclusions
- Develop responses to safety-related inquiries from regulatory agencies and ethics committees
- Ensure staff are compliant with Amgen corporate and departmental training and SOP review
- Provide training, coaching, mentoring, and development of staff.
Requirements:
- Doctorate degree and 5 years of global safety experience or Master’s degree and 9 years of global safety experience or Bachelor’s degree and 11 years of global safety experience
- at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- MD or DO degree from an accredited medical school with 6 years of directly related experience or PhD with 15 years of directly related experience preferred
- Clinical experience in either an accredited academic setting or private practice (including hospital based) setting preferred
- Experience in Obesity and/or Cardiometabolic conditions preferred
- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources preferred
- Previous product safety experience preferred.
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- 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
- Flexible work models where possible.
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