Senior Principal Scientist/Associate Director Clinical PBPK (Dual Level Posting)
Core
Develop and apply translational physiologically based pharmacokinetic (PBPK) modeling to facilitate drug discovery, development, and translational research across disease areas.
Role type
Senior Principal Scientist/Associate Director Clinical PBPK Modeler
Builds
Translational PBPK models for drug discovery and development
Domain
Pharmaceutical industry, Drug Discovery & Development, Biopharmaceutics
Deliverable
production ML models | product features
Required skills
PBPK modeling, ADME/DMPK principles, biopharmaceutics knowledge, regulatory submission experience, in vitro and in vivo data integration, drug-drug interaction (DDI) assessment, clinical trial design optimization
Preferred skills
Bespoke PBPK model development, formulation change support, clinical biowaiver generation
Technologies
GastroPlus, Simcyp, PK-Sim, Monolix, R, Phoenix, Nonmem
Responsibilities
Provide translational modeling support for global drug discovery and development projects; Perform translational PBPK analyses to predict clinical drug exposure in specific populations; Integrate PK/PD data, ADME and DDI findings; Prepare summary documents for regulatory submissions; Respond independently to health authority questions
Seniority
Senior, hands-on IC / Principal, strategy & mentorship