Director, Oncology Clinical Pharmacology Modeling & Simulation
Core
Lead Clinical Pharmacology Modeling and Simulation (CPMS) activities to inform oncology drug development decisions, ensuring therapies reach the right patients at the right dose and time.
Role type
Director, Clinical Pharmacology Modeling & Simulation (IC with leadership)
Builds
Clinical development programs, registration packages, and model-informed drug development strategies for oncology small molecules, biologics, and antibody drug conjugates.
Domain
Biopharmaceuticals / Oncology / Clinical Pharmacometrics
Deliverable
production ML models
Required skills
Clinical pharmacology, modeling and simulation, pharmacokinetics, pharmacodynamics, NONMEM, Monolix, R, FDA/ICH guidelines, study design, meta-analysis, regulatory submissions
Preferred skills
Oncology drug development, tumor size kinetics, joint models, model-based meta-analysis, adaptive dosing simulations, mechanistic PKPD modeling
Technologies
NONMEM, Monolix, R
Responsibilities
Design efficient clinical development programs and registration packages; predict human dose range and characterize exposure-response relationships; develop mathematical models for disease progression and drug PK/PD; conduct simulations to assess trial design performance; present CPMS strategy to project teams and regulatory agencies; write sections of drug development and registration documents; advocate for model-informed drug discovery and development.
Seniority
Director, strategic leadership with hands-on technical expertise