Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy
Core
Lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development, focusing on clinical dose selection, predictive PK/PD modeling, and regulatory strategies.
Role type
Director, Quantitative Clinical Pharmacology (PK/PD Modeling & Strategy)
Builds
Clinical development strategies, study protocols, model-based analyses, and regulatory submissions for gene therapies targeting muscle, CNS, and cardiac diseases.
Domain
Biopharmaceuticals / Gene Therapy / Clinical Pharmacology
Required skills
Clinical pharmacology principles, PK/PD modeling analysis, regulatory interactions, population PK, meta-analysis, disease modeling, NONMEM, R
Preferred skills
siRNA development, CNS disease modeling, manuscript publication, conference presentation
Technologies
NONMEM, R
Responsibilities
Drive quantitative pharmacology strategies across all stages of drug development; lead clinical pharmacology expertise in protocol preparation and data review; perform model-based data analyses including population PK and PK/PD simulation; serve as functional lead for global regulatory strategies and health authority engagements.
Seniority
Director, strategic leadership with hands-on technical execution
