Scientist II, Clinical Pharmacology & Pharmacometrics
Core
Formulate and deliver clinical pharmacology and pharmacometrics (CP&MS) strategy for oncology drug development assets, utilizing PK/PD, PBPK, and modeling & simulation to inform dose selection and go/no-go decisions.
Role type
Scientist II, Clinical Pharmacology & Pharmacometrics (IC)
Builds
Integrated clinical pharmacology roadmaps to registration and new product labels for oncology therapeutics
Domain
Oncology drug development / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Oncology quantitative pharmacology, Clinical pharmacology strategy, PK/PD analysis, Physiologic based PK (PBPK), Pharmacometric modeling & simulation (M&S), Regulatory document preparation, Study design and execution oversight, Data analysis and reporting
Preferred skills
Translational drug discovery and development, Experience with antibody-drug conjugates (ADCs) and radioligand therapies (RLTs), Global health authority interaction
Technologies
NONMEM, MONOLIX, Gastroplus, Simcyp, R, R-shiny, SAS, MATLAB, WINNONLIN
Responsibilities
Formulate 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 design, protocol preparation, execution, and regulatory document preparation.
Seniority
Mid-level Scientist, hands-on IC
