Senior Director, QSP/ PBPK Modeling

Role: Senior Director of QSP/PBPK Modeling, leading the development and application of quantitative pharmacology models to support drug discovery and clinical development for biopharma programs, with an emphasis on immunology and inflammation. Responsibilities: design, validate, and implement empirical (nonlinear mixed effects, exposure–response) and mechanistic (PBPK, QSP, systems PK/PD) models; integrate non-clinical and clinical data to inform human PK, dose selection, and trial design; support FIH, dose escalation, and proof-of-concept studies; drive model-informed drug development strategies; author and review regulatory modeling documentation; evaluate new methodologies and ensure regulatory readiness. Requirements: Ph.D. in Pharmacology, Pharmaceutics, Biomedical Engineering, or related field; 10+ years in quantitative pharmacology, pharmacometrics, or systems pharmacology within biotech/pharma R&D; proven leadership and experience in modeling software (e.g., SimBiology, Gastroplus, Monolix, R); ability to communicate complex concepts and work collaboratively. High-value: emphasis on immunology/inflammation, early-stage development, regulatory interactions, and model-informed decision making. Work setup: onsite in Lexington, MA, five days a week.