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 pharmacometrician (MIDD strategy lead)
Builds
Quantitative evidence packages for regulatory submissions and asset strategy refinement
Domain
Pharmaceutical drug development / Pharmacometrics
Deliverable
production ML models
Required skills
Population pharmacokinetic (PPK) modeling, exposure-response (E-R) modeling, data wrangling, quantitative data analysis, regulatory decision-making, scientific mentorship
Preferred skills
Quantitative Systems Pharmacology (QSP), Physiologically Based Pharmacokinetic (PBPK) modeling
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; Mentor junior scientists in PMx and MIDD
Seniority
Senior, hands-on IC