Principal Scientist - Clinical Pharmacology Modeling and Simulation
On-siteThousand Oaks, California, United States
Job Summary
Lead clinical pharmacology strategy for development programs from early clinical trials through registration and post-approval phases. Develop integrated plans addressing PK, PD, exposure-response, and dose selection, while designing and overseeing studies including first-in-human, drug-drug interaction, and ADME trials. Plan starting dose escalations by integrating nonclinical data, toxicology, and translational biomarkers. Interpret population PK, exposure-response, and quantitative analyses to support study design, Ph1-3 dose selection, and regulatory submissions. Provide scientific oversight for modeling and simulation plans, collaborate with cross-functional teams to resolve regulatory questions, and communicate complex concepts to health authorities and governance bodies.
Required Qualifications
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
- 2 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
- Master's degree and 5 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
- Bachelor's degree and 7 years of clinical pharmacology, pharmacometrics, modeling and simulation, or related drug-development experience
Desired Qualifications
- PhD, PharmD, MD, or equivalent advanced degree in Pharmaceutical Sciences or Pharmacology, Chemical Engineering, or related quantitative discipline
- 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
- Demonstrated experience developing and executing clinical pharmacology strategies across drug development, including dose and regimen selection, study design, ER assessment, and regulatory support
- Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on population PK, PK/PD modeling, PBPK modeling, and QSP modeling to inform development decisions
- Experience designing, overseeing, and interpreting clinical pharmacology studies, including first-in-human, DDI, food-effect, ADME, special population, BA/BE, or bridging studies
- Established track record of contributing to regulatory submissions, health-authority interactions, responses to regulatory questions, and product labeling
- Strong scientific judgment, leadership through influence, cross-functional collaboration, and written and verbal communication skills
- A record of scientific accomplishment demonstrated through successful program contributions, regulatory impact, publications, presentations, or other evidence of external scientific influence
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.