Director, CPMS Oncology
Core
Lead quantitative clinical pharmacology and modelling & simulation (CPMS) strategies for oncology drug development programs to inform dose selection, trial design, and regulatory submissions.
Role type
Director, Clinical Pharmacology Modelling and Simulation (CPMS)
Builds
Oncology therapies including antibody drug conjugates, biologics, and small molecules
Domain
Biopharmaceuticals / Oncology / Clinical Pharmacometrics
Deliverable
production ML models | product features
Required skills
Population PK and exposure-response modelling, NONMEM or R proficiency, model-based analysis of clinical data, regulatory document writing, drug-disease modeling, quantitative systems pharmacology, AI/ML informed analyses
Preferred skills
Oncology drug development experience, mechanistic PKPD modelling, longitudinal disease modeling, adaptive dosing simulations, MID3 implementation
Technologies
NONMEM, R
Responsibilities
Define and execute model-based development strategies; plan, conduct, and report population PK and exposure-response analyses; present strategy to governance boards and regulatory agencies; contribute to clinical program design and regulatory submissions; implement best practices in CPMS; promote model-informed drug discovery through external collaboration and publications
Seniority
Director, strategic leadership with hands-on technical expertise
