Clinical Pharmacology Lead (Manager)
Core
Manager leading clinical pharmacology and Model-Informed Drug Development (MIDD) for Internal Medicine drug portfolios to optimize study designs and dosage regimens.
Role type
Manager, Clinical Pharmacology Lead (MIDD)
Builds
Clinical development plans, PK/PD models, regulatory documents, and optimal study designs for new drug candidates.
Domain
Pharmaceutical R&D, Clinical Pharmacology, Model-Informed Drug Development (MIDD)
Deliverable
production ML models | product features
Required skills
mechanistic PK/PD modeling, population modeling, clinical trial simulations, NONMEM, R, literature meta-analyses, protocol authoring, regulatory document preparation, dose-range finding strategies
Preferred skills
leadership in multifunctional teams, scientific publications, presentation at scientific societies
Technologies
NONMEM, R
Responsibilities
Design and execute clinical pharmacology plans; oversee clinical phase activities and reporting; integrate PK/PD knowledge to optimize doses and study designs; contribute to regulatory submissions; influence external scientific environment.
Seniority
Manager, hands-on IC with leadership responsibilities
