R&D Clinical Pharmacokinetics & Pharmacometrics Prin. Scientist
Core
Lead clinical pharmacology and pharmacometrics strategy, trial design, dosing selection, and regulatory approval for drug development.
Role type
Principal Scientist, People Manager
Builds
Model-Informed Drug Development (MIDD) strategies and regulatory submissions
Domain
Pharmaceutical Development, Clinical Pharmacology, Pharmacometrics
Deliverable
production ML models
Required skills
Clinical Pharmacology, Pharmacometrics, Modeling & Simulation (Population PK, Exposure-Response, PBPK), Non-clinical ADME, Regulatory Affairs (PMDA, CTD), People Management, Strategic Thinking
Preferred skills
Global development strategy leadership, Cross-functional stakeholder management, Capability building, AI/data science integration
Technologies
Population PK, PK-PD, Exposure-Response, PBPK, MIDD
Responsibilities
Lead CP2 group, drive MIDD, manage regulatory interactions, align global and Japan strategies, mentor team members, build organizational capability
Seniority
Principal, People Manager