Director Clinical Pharmacology
Core
Lead clinical pharmacology and PK-PD strategies, guide PK-PD assessments, and drive modeling and simulation to support drug development decisions across the clinical lifecycle.
Role type
Director, Clinical Pharmacology (Strategy & Cross-functional Leadership)
Builds
Innovative therapies for immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas
Domain
Biopharmaceuticals / Clinical Drug Development
Required skills
Clinical pharmacology strategy, PK-PD analysis, population pharmacokinetics, modeling and simulation, regulatory submission expertise, cross-functional collaboration, study design oversight, biomarker integration, external scientific engagement
Preferred skills
Clinical pharmacology research fellowship, experience with translational science teams
Technologies
Non-compartmental analysis, population pharmacokinetic methodologies, modeling and simulation tools
Responsibilities
Lead clinical pharmacology and PK-PD strategies for assigned programs; Lead design of clinical pharmacology studies and protocol sections; Plan and implement PK/PD analyses; Review and interpret clinical pharmacology study results; Represent clinical pharmacology in cross-functional development teams; Apply pharmacometric methodologies for dose selection and study design; Provide expertise for regulatory submissions and health authority responses; Partner with translational science for preclinical PK-PD knowledge; Establish relationships with external scientific experts
Seniority
Director, strategic leadership with hands-on scientific expertise