Senior Director, QSP/ PBPK Modeling

Senior Director of QSP/PBPK Modeling

Key Responsibilities

• Lead the design, development, validation, and application of pharmacology models, including empirical (nonlinear mixed effects, exposure–response) and mechanistic models (PBPK, QSP, systems PK/PD).
• Integrate non-clinical PK/PD, efficacy, and biomarker data with emerging clinical PK/PD and biomarker data to support human PK predictions, dose selection, and clinical trial design.
• Provide quantitative support for first-in-human (FIH), dose escalation, and proof-of-concept studies.
• Drive model-informed drug development (MIDD) strategies across programs to influence development and portfolio decisions.
• Partner with Clinical Pharmacology and Translational Medicine to align pharmacology modeling, bioanalytical strategies, and clinical endpoints.
• Author/review modeling sections for INDs, IBs, clinical study reports, and regulatory briefing documents; support regulatory interactions as an SME.
• Ensure scientific rigor, documentation quality, and regulatory readiness of modeling deliverables.
• Evaluate and implement new modeling methodologies, platforms, and best practices.

Required Qualifications

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, or related quantitative field.
• 10+ years in quantitative pharmacology, pharmacometrics, or systems pharmacology (biotech/pharma R&D), with progression to scientific leadership.
• Deep hands‑on expertise in nonlinear mixed-effects modeling and mechanistic PK/PD modeling (PBPK, TMDD, systems pharmacology), translating non‑clinical PK/PD to human dose prediction using tools such as Matlab/SimBiology, OSP Suite, Simcyp, Gastroplus, Monolix, and R.
• Strong understanding of drug development, clinical trial design, and regulatory expectations for pharmacology/pharmacometrics; experience using modeling for clinical decision‑making in early‑stage development.
• Ability to clearly communicate complex quantitative concepts to multidisciplinary, non-modeling audiences.

Pay Range

$281,000 - $299,000 USD

Work Location

Lexington, MA office; onsite five days per week