Global Safety Medical Director (GSO) - Hematology / Oncology, US- Remote

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 Medical Director - Hematology/Oncology





What you will do



Let’s do this. Let’s 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 to worldwide regulations.



The Global Safety Officer (GSO) serves 2 roles:



Safety 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. The GSO will be assigned as delegate for the TAH as needed.



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





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



Previous management and/or mentoring experience



Experience in the study/research and/or treatment of Hematology and Oncology disease states





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, 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 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





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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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