Sr. Principal Scientist - Project Toxicologist
Amgen · Remote
ResearchRemoteFull-timeCompany career page
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Role summary
Senior Principal Scientist position supporting drug development programs as a Project Toxicologist and nonclinical safety subject matter expert. Responsible for designing safety strategies, leading multidisciplinary teams, and serving as regulatory interface from discovery through post-marketing across diverse therapeutic modalities.
What they're looking for
- PhD, PharmD, or MD with 3+ years as nonclinical safety project team representative
- Or Master's degree with 6+ years PTR experience in drug development
- Or Bachelor's degree with 8+ years PTR experience
- 8+ years post-PhD industry experience preferred, including 5+ years as toxicologist/safety PTR
- Board certification in toxicology preferred
- Demonstrated leadership of toxicology programs supporting nonclinical safety assessment
- Extensive experience authoring regulatory documents and engaging with FDA and international agencies
What you'll be doing
- Serve as toxicology and nonclinical safety representative on project teams providing scientific leadership
- Design, implement, manage and interpret nonclinical safety assessment programs for drug candidates
- Develop novel study designs and protocols addressing complex safety questions
- Author regulatory documents including INDs, BLAs, NDAs and governance materials
- Mentor Amgen scientists in nonclinical study design, execution and oversight
Privacy & handoff
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