Principal Scientist, Clinical Pharmacology & Pharmacometrics
Core
Lead clinical pharmacology and pharmacometric strategy for oncology drug development, informing dose selection and go/no-go decisions.
Role type
Principal Scientist, Clinical Pharmacology & Pharmacometrics
Builds
Oncology therapeutics including antibody-drug conjugates (ADCs) and radioligand therapies
Domain
Oncology / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models | dashboards & analysis
Required skills
oncology quantitative pharmacology, clinical pharmacology strategy, PK/PD modeling, PBPK modeling, pharmacometric modeling & simulation, regulatory document preparation, study design, protocol preparation, data analysis, regulatory guidance knowledge
Preferred skills
ADC and/or RLT development experience, translational drug discovery, integrated clinical pharmacology roadmap to registration
Technologies
NONMEM, MONOLIX, WINNONLIN, Gastroplus, Simcyp, R, R-shiny, SAS, MATLAB
Responsibilities
Formulate and deliver CP&MS strategy for late-stage and early preclinical/clinical assets; Apply PK/PD, PBPK, and M&S approaches to characterize drug absorption/disposition and assess drug effect dynamics; Work with CROs and scientists to conduct/monitor clinical pharmacology studies; Contribute to program strategy, study execution, data review, and regulatory submissions
Seniority
Principal, strategy & mentorship
