Safety Pharmacology Senior Scientist
Listed on 2026-08-06
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Research/Development
Pharmaceutical Science/ Research, Regulatory Compliance Specialist
Safety Pharmacology Senior Scientist
Join Amgen's mission of serving patients. At Amgen, if you feel like you are 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions.
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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will doIn this vital role you will join the Safety Pharmacology Sciences team. The successful candidate will serve as a subject matter expert in nonclinical safety pharmacology, partnering closely with project teams to develop and execute integrated safety pharmacology strategies that support discovery, candidate selection, IND‑enabling packages and regulatory submissions. This role will require strong scientific judgment, regulatory awareness, cross‑functional collaboration, and the ability to translate complex nonclinical safety pharmacology data into clear, actionable recommendations for project teams and governance forums.
The Senior Scientist will work closely with Safety Pharmacology Sciences colleagues to shape and deliver high‑quality safety pharmacology strategies across Amgen’s portfolio to support high‑quality development decisions to enable progression of innovative therapeutics for patients. The role includes opportunities to contribute to Amgen’s external scientific influence through collaborations, presentations, publications, or participation in industry working groups.
- Serve as a Safety Pharmacology subject matter expert on cross‑functional project teams, developing fit‑for‑purpose strategies and providing strategic guidance across discovery, lead optimization, candidate selection, IND‑enabling, and clinical development stages, aligned with program biology, modality, target risk, regulatory expectations, and development needs.
- Design and oversee GLP and non‑GLP safety pharmacology studies conducted internally or at external contract research organizations, ensuring scientific rigor, operational feasibility, compliance, and timely delivery.
- Evaluate and integrate nonclinical safety pharmacology data, including cardiovascular, respiratory, CNS, ECG, hemodynamic, telemetry, and related endpoints, to assess biological relevance, translational significance, and regulatory impact.
- Integrate safety pharmacology data with toxicology, pharmacology, translational biology, DMPK, clinical, and regulatory information to support weight‑of‑evidence decision‑making.
- Contribute to internal governance presentations, project team discussions, regulatory strategy meetings, development milestone decisions, and resolution of study‑related scientific or technical issues.
- Contribute to safety pharmacology sections of regulatory documents, including IND‑enabling summaries, Investigators Brochures, briefing documents, responses to regulatory questions, and internal development reports.
- Contribute to development and implementation of innovative safety pharmacology approaches, including fit‑for‑purpose study designs, risk‑based assessment frameworks, and translational safety strategies.
- Stay current with evolving regulatory expectations, industry best practices, scientific literature, and emerging methodologies in safety pharmacology.
- Participate in internal initiatives to improve safety…
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