Associate Director, Translational Quantitative Pharmacology; TQP

Work Location:

Billerica, Massachusetts

Location:

Hybrid (3x/week in office) role based in Billerica, MA

Department: HC-RD-BQ4G Global Translational Quantitative Pharmacology

Recruiter:
Sarah Ellis

The role of Associate Director, Translational Quantitative Pharmacology, in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization, is a scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) strategies including quantitative systems pharmacology (QSP) platform models across the R&D lifecycle.

This position will be responsible for all TQP assignments either executed internally or in collaboration with external TQP related CROs by providing close scientific and technical supervision. The incumbent will be expected to manage multiple projects simultaneously and participate in discussions and presentations.

The role requires the candidate to also communicate TQP related science and strategies to all interfacing disciplines at the project or non-project levels and help develop modeling toolboxes to assist project teams in making quantitative decisions.

This position reports to the Global Head of Translational Quantitative Pharmacology.

• To be an independent contributor in the field of translational quantitative pharmacology to help advance the fundamental science of the field, to help guide, educate, mentor and contribute to the success of the discipline within the company.
• To be able to independently develop QSP models that will inform compound progression decisions from lead optimization to clinical proof of concept and beyond for the immunology and oncology pipelines for all modalities of interest.
• Responsible for performing human PK predictions and quantitative DDI predictions, the design and analysis of pre-clinical PK/PD experiments and data to support preclinical development, and translational PK/PD analyses to support FIH dose estimates for all modalities of interest.
• To develop models or use commercially available software tools to understand and quantify toxicological signals such as cardiovascular, hepatic, renal, dermal, and heme to determine the therapeutic index and help guide project decisions.
• To be able to interact with various project team members in a clear and timely manner, understanding the functions of other team members and being able to explain and educate model‑based analyses and results to team members from various backgrounds.
• Work in a dynamic team with frequent interactions, both within the team and with associated functions, and will be responsible for the development and implementation of innovative modeling and simulation platforms/strategy that ensure that the right drug is administered to the right patient at the right dosage.
• As a member of project teams and sub-teams, the incumbent will represent QP and present analysis outcomes to cross‑functional teams, at department meetings, project review committees and conferences.
• The candidate will contribute to the preparation and presentation of both internal and external documentation (e.g. Investigator’s Brochure, IND, CTD) and program strategy.

• A PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical/Chemical Engineering, Applied Mathematics, or a related discipline
• A minimum of 5 years in industry and/or academia in a relevant background with proven track record of applying modeling and simulation approaches to biological problems
• Position requires both domestic and international travel up to 20% of time

• Sound knowledge of the theory and principles of Quantitative Systems Pharmacology plus hands‑on competence in mathematical modeling of pharmacologic effects with mechanism‑based models using relevant software or programming languages (e.g., MATLAB/Sim Biology, NONMEM, R, Monolix).
• 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.
• Knowledge of basic principles of biology and pharmacology at the organismal, cellular and…