Global Safety Medical Director, Early Development Rare Disease

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.

Let's do this. Let's change the world. In this vital role you will serve as the strategic safety leader for assigned Rare Disease assets across early and late-stage clinical development and, where applicable, post-marketing activities. You will be accountable for the ongoing benefit-risk assessment, safety strategy, signal detection and evaluation, regulatory safety deliverables, and cross-functional leadership required to support global development programs and bring innovative therapies to patients.

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.

• Lead safety strategy for early clinical development programs, including First-in-Human, dose-escalation, proof-of-concept, and Phase 1-2 studies
• Provide medical safety input into clinical development plans and key development decisions, including dose selection, safety monitoring approaches, and benefit-risk assessments
• Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums
• Interpret emerging safety data and communicate safety implications to development teams and senior governance committees
• 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
• Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, safety monitoring plans, and Clinical Study Reports to ensure appropriate safety data collection and evaluation
• 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%

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…