Associate Director, Precision Medicine
Core
Leads the development and implementation of the Model-Informed Drug Development (MIDD) strategy for drugs in clinical development, integrating diverse data through pharmacometric (PMx) models to inform regulatory decision-making.
Role type
Senior IC quantitative pharmacometrics lead (MIDD strategy)
Builds
Quantitative evidence packages for regulatory submissions and asset strategy decisions
Domain
Pharmaceutical drug development / Pharmacometrics
Deliverable
production ML models
Required skills
Population pharmacokinetic (PPK) modeling, exposure-response (E-R) modeling, data wrangling, R, NONMEM, Monolix, Pumas, MATLAB, Python, Julia, regulatory strategy, mechanistic modeling (QSP, PBPK)
Preferred skills
Mechanistic modeling approaches (QSP, PBPK), mentoring junior scientists
Technologies
R, NONMEM, Monolix, Pumas, MATLAB, Python, Julia
Responsibilities
Develop MIDD strategy and PMx plan for assigned assets, lead integration across quantitative disciplines, plan and execute formal PMx analyses for regulatory submissions, translate modeling results into actionable recommendations, provide scientific direction for external vendor analyses, represent MIDD strategy with health authorities, advance PMx infrastructure and methodologies, mentor junior scientists
Seniority
Senior, hands-on IC with strategic oversight