Manager, Clinical Pharmacology
Core
Lead clinical pharmacology expertise for oncology development programs, designing studies and optimizing dosing regimens.
Role type
Manager, Clinical Pharmacology
Builds
Clinical Study Protocols, Clinical Pharmacology plans, regulatory documents (Investigator Brochures, EOP2 responses)
Domain
Oncology drug development, Clinical Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD analysis, population PK modeling, dose optimization, regulatory document preparation, cross-functional collaboration
Preferred skills
R, NONMEM, Monolix, drug-drug interaction analysis, special group dosing strategies
Technologies
R, NONMEM, Monolix
Responsibilities
Provide clinical pharmacology components to Clinical Study Protocols and Reports; Plan and oversee clinical pharmacology studies; Execute PK/PD analyses and simulations; Provide recommendations for clinical doses and dosing regimens; Support resolution of regulatory agency queries; Collaborate with pharmacometrics and statistics groups.
Seniority
Manager, hands-on IC
