Associate Director, Translational Quantitative Pharmacology (TQP)

Merck•Billerica, MA

1d•Hybrid

About The Position

The role of Associate Director, Translational Quantitative Pharmacology (TQP), within the Quantitative Pharmacology group and the broader Clinical Measurement Sciences organization, is a scientific and cross-functional role. This position is responsible for developing and executing Model Informed Drug Development (MIDD) strategies, including quantitative systems pharmacology (QSP) platform models, across the R&D lifecycle. The incumbent will provide close scientific and technical supervision for all TQP assignments, whether executed internally or in collaboration with external TQP CROs. The role requires managing multiple projects simultaneously, participating in discussions and presentations, and communicating TQP-related science and strategies to interfacing disciplines. Additionally, the position involves developing modeling toolboxes to aid project teams in making quantitative decisions. This position reports to the Global Head of Translational Quantitative Pharmacology.

Requirements

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 a proven track record of applying modeling and simulation approaches to biological problems.
Position requires both domestic and international travel up to 20% of time.

Nice To Haves

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/SimBiology, 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 molecular level, preferably in one or more of the following areas: oncology, immuno-oncology, immunology.
Ability to rapidly assimilate knowledge of complex biology of drug action for novel mechanisms and transform such understanding into multi-scale mathematical models, with requisite mathematical and computational proficiency.
Experience in applying PBPK modeling and simulation using relevant software (e.g., MATLAB, Simcyp, GastroPlus) is a plus.
Flexibility and keen pursuit of innovation throughout all phases of the drug discovery and development process.
A desire to develop and grow by way of taking responsibility and engaging in additional tasks and operations.
Ability to work independently and deliver results in a timely manner.
Publications in conference proceedings and peer-reviewed journals is desirable.

Responsibilities

Develop and execute Model Informed Drug Development (MIDD) strategies, including quantitative systems pharmacology (QSP) platform models, across the R&D lifecycle.
Provide close scientific and technical supervision for all TQP assignments, whether executed internally or in collaboration with external TQP CROs.
Manage multiple projects simultaneously and participate in discussions and presentations.
Communicate TQP-related science and strategies to all interfacing disciplines at the project or non-project levels.
Develop modeling toolboxes to assist project teams in making quantitative decisions.
Independently develop QSP models to 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.
Perform human PK predictions and quantitative DDI predictions.
Design and analyze pre-clinical PK/PD experiments and data to support preclinical development.
Conduct translational PK/PD analyses to support FIH dose estimates for all modalities of interest.
Develop models or use commercially available software tools to understand and quantify toxicological signals (e.g., cardiovascular, hepatic, renal, dermal, heme) to determine the therapeutic index and guide project decisions.
Interact with various project team members in a clear and timely manner, understanding their functions and educating them on model-based analyses and results.
Develop and implement innovative modeling and simulation platforms/strategy to ensure the right drug is administered to the right patient at the right dosage.
Represent QP and present analysis outcomes to cross-functional teams, department meetings, project review committees, and conferences.
Contribute to the preparation and presentation of both internal and external documentation (e.g., Investigator’s Brochure, IND, CTD) and program strategy.
Mentor, educate, and explain modeling concepts and approaches to colleagues within QP/CMS and the larger organization.
Publish in conference proceedings and peer-reviewed journals.