Global Safety Medical Director (GSO) - Hematology/...

Global Safety Medical Director (GSO) - Hematology/Oncology, US- RemoteJoin Amgen's Mission of Serving PatientsAt Amgen, 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.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.Global Safety Medical Director - Hematology/OncologyWhat You Will DoLets do this. Lets change the world. In this vital role, you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations.The Global Safety Officer (GSO) Serves 2 RolesSafety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio.The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross-functional teams.Key activitiesValidate safety signals and lead safety signal assessmentsDevelop 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 measuresPrepare/review safety sections of periodic aggregate reportsProvide safety input to protocols, statistical analysis plans, and clinical study reportsPrepare/review safety sections of new drug applications and other regulatory filingsServe as safety expert on Evidence Generation Team for assigned productsInspection ReadinessWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic QualificationsMD or DO degree from an accredited medical schoolCompletion of an accredited medical or surgical residencyClinical experience in either an accredited academic setting or private practice (including hospital-based) settingPreferred QualificationsProduct safety in the bio/pharmaceutical industry or regulatory agencyPrevious management and/or mentoring experienceExperience in the study/research and/or treatment of Hematology and Oncology disease statesWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. #J-18808-Ljbffr

Created: 2025-10-07