Global Safety Medical Director, Hematology Oncology

Career Category Safety Job Description 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. Global Safety Officer, Medical Director What you will do Let’s do this. Let’s change the world. In this vital role you will serve as the safety expert of the assigned product(s) within the Hematology Oncology portfolio. You will 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. You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). Serve as a member of the Evidence Generation Team and other relevant cross-functional teams and will be assigned as delegated for the Therapeutic Area Head (TAH). 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 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 Domestic and International travel up to 10% What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Global Safety Officer we seek is a leader with 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 Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Expertise in Hematology Oncologytherapeutic area, or clinical training. Experience with marketed product safety; risk management Experience with phase 1-3 clinical trials safety assessments and