Scientific Director, Translational Quantitative Pharmacology; TQP

Scientific Director – Translational Quantitative Pharmacology

In the Quantitative Pharmacology section of the broader Clinical Measurement Sciences organization, this scientific and cross‑functional role is responsible for developing and executing Model Informed Drug Development (MIDD) plans and strategies from early translational research to late‑stage clinical development. The incumbent will work with cross‑functional drug discovery and development project teams, collaborating closely with Clinical Pharmacology, Pharmacometrics, Biostatistics, Data Sciences, Patient‑Focused Real‑World Evidence, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other R&D colleagues.

This position reports to the Global Head of Translational Quantitative Pharmacology. The role requires an independent modeler who can strengthen quantitative systems pharmacology (QSP) platform and fit project capabilities by contributing to the strategic use of QSP and translational PK/PD methodologies across disease areas, aligning with the clinical development plan. The incumbent will provide close scientific and technical supervision, independently manage multiple projects simultaneously, and participate in discussions and presentations.

Hybrid (3 × week in office). The role is based in Billerica, MA.

• Act as an independent contributor in translational quantitative pharmacology and QSP, advancing foundational science, guiding, mentoring, and contributing to the discipline within the company.
• Independently develop QSP models that inform compound progression decisions from lead optimization to clinical proof of concept and beyond, covering immunology and oncology pipelines for all modalities.
• Perform human PK predictions and quantitative DDI predictions, and design and analyze pre‑clinical PK/PD experiments to support preclinical development, as well as translational PK/PD analyses to support first‑in‑human dose estimates for all modalities.
• Develop quantitative systems toxicology (QST) models or use commercial software to quantify toxicological signals (cardiovascular, hepatic, renal, dermal, hematologic) to determine therapeutic index and guide project decisions.
• Interact clearly and timely with various project team members, understanding their functions and explaining model‑based analyses and results across backgrounds.
• Collaborate with the team and associated functions to develop and implement innovative modeling and simulation platforms/strategies that ensure the right drug is administered to the right patient at the right dosage.
• Prepare and present internal and external documentation (e.g. Investigator’s Brochure, IND, CTD) and program strategy.

• PhD in Pharmaceutical Sciences, Biomedical/Chemical Engineering, Quantitative Biology, Systems Biology, or Applied Mathematics.
• 5+ years of experience with hands‑on systems modeling and application of MIDD principles in a drug‑development setting.
• Position requires both domestic and international travel up to 20% of time.

• Excellent knowledge of the theory and principles of Quantitative Systems Pharmacology and hands‑on competence in mathematical modeling of pharmacologic effects with mechanism‑based models using relevant software or programming languages (e.g., MATLAB/Sim Biology, Monolix, R).
• Advanced experience in applying translational PK/PD M&S including QSP approaches in research and early clinical development to inform confidence in target/mechanism, dose/regimen, and combinations.
• Solid knowledge of basic principles of biology and pharmacology at the organismal, cellular and molecular level, preferably in oncology, immuno‑oncology, immunology, and molecular biology.
• Ability to rapidly assimilate knowledge of complex biology of drug action for novel mechanisms and transform that understanding into multi‑scale mathematical models, with requisite mathematical and computational proficiency.
• Experience in applying PBPK modeling and simulation using relevant software or ability to build PBPK models from the ground up (e.g., MATLAB, Simcyp, Gastro Plus).
• Ability to mentor, educate and…