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