Global Safety Medical Director - Obesity

Career CategorySafetyJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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 Medical Director, ObesityWhat you will doLet’s do this. Let’s change the world. 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 the strategy, direction, and priorities of pharmacovigilance activities and will be 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) 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 have management of Global Safety Physicians.Responsibilities:Validate 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 ReadinessTravel: Domestic and International travel ~10% may be requiredWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Medical Safety professional we seek has these qualifications.Basic Qualifications:MD or DO degree from an accredited medical schoolANDCompletion of an accredited medical or surgical residencyORClinical experience in either an accredited academic setting or private practice (including hospital based) settingAND4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:Industry pharmacovigilance (PV) experienceProduct safety in the bio/pharmaceutical industry or regulatory agencyPrevious management and/or mentoring experienceBoard certification or equivalent trainingExpertise in Obesity/Cardiovascular therapeutic areaLeadership experience within the safety profile of products assigned with cross-functional team membersWhat 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.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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen d