Global Safety Medical Director, Immuno-oncology

Location: Washington
Posted on: June 23, 2025

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Medical Director What you will do Lets do this. Lets change the world. In this vital role you will serve as the safety expert of the assigned product(s) within the Rare Disease 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 dynamic professional we seek is a leader with these qualifications. Basic 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 Rare Disease 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 As 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, well 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, based on eligibility, comprising of 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 that may include: 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 Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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