Principal Scientist - Clinical Pharmacology Modeling and Simulation
Amgen · Thousand Oaks, CA
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Role summary
This principal scientist role leads clinical pharmacology strategy across drug development programs, from early-stage studies through regulatory approval. The position involves designing clinical pharmacology studies, analyzing exposure-response data, and collaborating with cross-functional teams to inform dose selection, study design, and regulatory submissions.
What they're looking for
- PhD, PharmD, or MD with 2+ years clinical pharmacology drug development experience
- Master's degree with 5+ years clinical pharmacology or modeling/simulation experience
- Bachelor's degree with 7+ years clinical pharmacology or related drug development experience
- Experience developing clinical pharmacology strategies across dose selection and study design
- Hands-on quantitative expertise in population PK, PK/PD modeling, and exposure-response analysis
- Track record designing and interpreting clinical pharmacology studies including first-in-human trials
- Ability to communicate complex quantitative concepts and influence strategy through data-driven recommendations
What you'll be doing
- Serve as clinical pharmacology lead for development programs from early clinical stages through registration
- Develop integrated clinical pharmacology plans addressing PK, PD, dose selection, and special populations
- Design, oversee, and plan timing for clinical pharmacology studies including first-in-human and drug-drug interactions
- Lead FIH starting dose and escalation decisions by integrating nonclinical and translational data
- Contribute clinical pharmacology expertise to protocols, regulatory submissions, and product labeling documentation
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.