Global Safety Medical Director, Hematology Oncology

What We Do

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re 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 1980, 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 transforming your career.

What You Will Do

• Serve as the safety expert of the assigned product(s) within the Hematology Oncology portfolio.
• Establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
• Lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).
• Work in a fast-paced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.

Key Activities

• 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.
• 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.

What We Expect Of You

• 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.
• Product safety in the bio/pharmaceutical industry or regulatory agency.
• Expertise in Hematology Oncology therapeutic area, or clinical training.
• Experience with marketed product safety; risk management.
• Experience with phase 1-3 clinical trials safety assessments and analyses.
• Drug Submission experience.
• Leadership experience of the safety profile of products assigned with cross-functional team members.

What You Can Expect Of Us

• 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, 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.
• Flexible work models, including remote and hybrid work arrangements, where possible.

Pay & Benefits

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.

Application

To apply for this role, please visit careers.amgen.com.