Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and Simulation
Core
Strategic leadership for Oncology Clinical Pharmacology Modeling and Simulation (CPMS) to accelerate oncology therapy development and optimize trial design.
Role type
Executive Director, Clinical Pharmacology (Strategy & Leadership)
Builds
Oncology drug development programs and regulatory dossiers
Domain
Biopharma / Oncology / Clinical Pharmacology
Deliverable
production ML models
Required skills
Clinical PK/PD analysis, Population PK, PBPK, regulatory dossier authoring, matrix team management, translational research strategy, risk management
Preferred skills
ADC/TCE/small molecule/antibody experience, quantitative modeling, cross-functional collaboration, regulatory guidance knowledge (ICH/FDA/EMA)
Technologies
Population PK, PBPK, AI, Molecular Modeling
Responsibilities
Provide advanced technical support for oncology programs; manage CPMS Managers and Directors; design clinical pharmacology studies (rBA/BE, DDI, special population); develop modeling strategies for trial design and dosing; author regulatory sections; participate in regulatory meetings; implement best practices; define 18-24 month scientific strategy; develop talent and succession plans.
Seniority
Executive, strategic leadership & mentorship