R&D Clinical PK & Pharmacometrics Sr. Scientist
Core
Leverage clinical pharmacology and pharmacometrics to support drug development strategy, ensure early approval, and provide clinical pharmacology/PK information to clinical teams.
Role type
Senior Individual Contributor (IC) Clinical Pharmacometrics Scientist
Builds
Clinical trial protocols, PK analysis reports, regulatory submission documents, and modeling & simulation outputs.
Domain
Pharmaceutical R&D, Clinical Pharmacology, Pharmacometrics
Deliverable
Production ML models | dashboards & analysis | client delivery
Required skills
Clinical trial planning, Population PK/PD modeling, Non-compartmental PK analysis, Non-clinical ADME knowledge, Regulatory submissions, Oncology therapeutic knowledge
Preferred skills
Exposure-Response modeling, CDISC data standards, Cross-functional collaboration, International communication
Technologies
Modeling & Simulation (M&S) tools, CDISC standards
Responsibilities
Design clinical trial protocols (sample size, sampling points), perform PK analysis and create summary reports, prepare regulatory submission materials including non-clinical ADME sections, contribute to PMDA consultation discussions, mentor junior staff on M&S skills.
Seniority
Senior, hands-on IC with mentorship responsibilities
