Associate Director, Clinical Pharmacology Modeling and Simulation Oncology
Core
Lead quantitative clinical pharmacology and modeling and simulation activities for oncology R&D programs, from pre-FTIH through submission and life cycle management.
Role type
Associate Director, Clinical Pharmacology Modeling and Simulation (CPMS)
Builds
Clinical pharmacology and modeling and simulation excellence for oncology research and development programs
Domain
Biopharmaceuticals, Oncology, Clinical Pharmacology
Deliverable
production ML models | product features
Required skills
Population PK modeling, Exposure-response analysis, Mechanistic PKPD modeling, Longitudinal disease modeling, Model-based meta-analysis, Quantitative systems pharmacology, NONMEM, Monolix, R, Regulatory submission writing, Clinical program design
Preferred skills
Oncology R&D experience, Model-Informed Drug Development (MIDD) implementation, AI/ML for pharmacometrics, Drug-disease system knowledge
Technologies
NONMEM, Monolix, R
Responsibilities
Plan, conduct, and report population PK modeling, exposure-response analysis, simulation-based trial design, and dose selection; Apply innovative methods like longitudinal exposure-response analysis and QSP to enhance data use; Present strategy and defend model-based outcomes to governance boards and regulatory agencies; Contribute to clinical program design, trial protocols, analysis plans, and regulatory submissions; Write or review clinical pharmacology components of regulatory documents; Implement best practices from internal and external sources; Promote model-informed drug discovery through external collaboration and publications
Seniority
Associate Director, hands-on IC with strategic influence