Amgen

Global Safety Senior Director, PV – Obesity

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $229,628 - $274,119 per year

Job Level

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory safety submissionsBenefit/Risk Management Processsafety data analysiscore safety messagessafety-related inquiriescompliance trainingStandard Operating Proceduresclinical experienceproduct safety experiencemanagerial experience
Soft Skills
strategic oversightleadershipcoachingmentoringdevelopment of staffcommunicationteam managementresource allocationorganizational skillsproblem-solving
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeMDDOPhD