Associate Director Quantitative Pharmacology
Core
Lead model-informed drug development strategies for therapeutic areas including antibodies, siRNA, and gene therapies to inform dose selection, trial design, and regulatory strategy.
Role type
Associate Director, Quantitative Pharmacology
Builds
Drug development programs and regulatory submission documents
Domain
Biopharmaceuticals / Quantitative Pharmacology
Required skills
Population PK/PD modeling, Exposure–response modeling, Mechanistic modeling (systems biology/QSP), NONMEM, Monolix, Simulx, MATLAB/Simbiology, R, Regulatory submission preparation, Cross-functional leadership
Preferred skills
Publication record, Experience engaging with FDA/EMA/PMDA
Technologies
NONMEM, Monolix, Simulx, MATLAB, Simbiology, R
Responsibilities
Identify and provide significant pharmacometrics contributions for complex R&D programs, Design and conduct PMx analysis plans, Prepare nonclinical or clinical study reports and regulatory submission documents, Communicate complex strategies to development teams
Seniority
Senior, hands-on IC with leadership responsibilities