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Job description
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
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Worksite address
lexington, MA, 02173, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.