Director, Clinical Pharmacology
Core
Provide strategic and scientific leadership for clinical pharmacology across all stages of drug development, from First-in-Human through registration and life-cycle management.
Role type
Director, Clinical Pharmacology (Strategic IC)
Builds
Integrated clinical pharmacology strategies, dose selection plans, and regulatory submissions for novel therapeutics targeting metabolic dysfunction-associated steatohepatitis (MASH).
Domain
Biopharmaceuticals / Clinical Pharmacology / MASH
Required skills
Clinical pharmacology strategy, pharmacokinetics (PK), pharmacodynamics (PD), exposure-response analysis, dose selection and optimization, model-informed drug development (MIDD), regulatory submission preparation, bioanalytical planning, study design and interpretation.
Preferred skills
Experience with small molecule, siRNA, and biologic drugs, MASH and metabolic diseases, bioanalytical methods, data modeling tools (NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin).
Technologies
NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin
Responsibilities
Develop and execute integrated Clinical Pharmacology strategies; Lead dose selection and optimization; Design and oversee Phase 1 and dedicated Clinical Pharmacology studies; Provide input to Phase 1-4 clinical study design; Collaborate with Clinical Development, Translational Medicine, and Regulatory Affairs; Contribute to scientific publications and presentations.
Seniority
Director, strategic leadership with hands-on expertise