Global Safety Medical Director - Obesity

Join Amgen's mission of serving patients. At Amgen, if you feel like you are part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 2008, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while advancing your career.

In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for the assigned development product(s), establishing strategy, direction, and priorities of pharmacovigilance activities, and will be accountable for the overall safety profile and all product-related decisions and deliverables. You will also lead the Safety Analysis Team (SAT) and Global Safety Team (GST). In addition, you will participate as a member of the Evidence Generation Team and other relevant cross‑functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and will manage Global Safety Physicians.

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans, including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection readiness
• Travel:
  Domestic and International travel ~10% may be required

We are all different, yet we all use our unique contributions to serve patients. The medical safety professional we seek has these qualifications.

MD or DO degree from an accredited medical school
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital‑based) setting
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• Industry pharmacovigilance (PV) experience
• Product safety in the bio/pharmaceutical industry or regulatory agency
• Previous management and/or mentoring experience
• Board certification or equivalent training
• Expertise in Obesity/Cardiovascular therapeutic area
• Leadership experience within the safety profile of products assigned with cross‑functional team members

As we work to develop treatments that take care of others, we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we will support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, comprising Health and Welfare Plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental…