Scientific Director, Translational Quantitative Pharmacology (TQP)

Merck•Billerica, MA

1d•Hybrid

About The Position

The role of Scientific 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) plans and strategies from early translational to late-stage clinical development. The incumbent will work within cross-functional drug discovery and development project teams, collaborating closely with colleagues in Clinical Pharmacology, Pharmacometrics, Biostatistics, Data Sciences, Patient-Focused Real-World Evidence, Clinical Biomarkers and Diagnostics, Research, Clinical Development, and other R&D organization members. The role also involves participating in activities to strengthen the quantitative systems pharmacology (QSP) platform and project capabilities by contributing to the strategic use of QSP and translational PKPD methodologies across disease areas, aligned with the clinical development plan. Close engagement with key stakeholders is expected to ensure timely and high-quality pharmacometrics deliverables for the program. The incumbent will oversee translational modeling and simulation activities, whether executed internally or with external CROs, providing close scientific and technical supervision. The position requires the ability to independently manage multiple projects simultaneously and participate in discussions and presentations. This position reports to the Global Head of Translational Quantitative Pharmacology.

Requirements

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.
Domestic and international travel up to 20% of time.

Nice To Haves

Excellent 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, 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 one or more of the following areas: oncology, immuno-oncology, immunology, and molecular biology.
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 or ability to build PBPK models from the ground up (e.g., MATLAB, Simcyp, GastroPlus).
Ability to mentor, educate and explain modeling concepts and approaches to colleagues within QP/CMS and the larger organization.
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

Serve as an independent contributor in translational quantitative pharmacology and QSP, advancing the fundamental science of the field and contributing to the success of the discipline within the company.
Independently develop quantitative systems pharmacology (QSP) models to inform compound progression decisions from lead optimization to clinical proof of concept and beyond for immunology and oncology pipelines across all modalities.
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.
Develop quantitative systems toxicological (QST) models or utilize commercially available software tools to understand and quantify toxicological signals (e.g., cardiovascular, hepatic, renal, dermal, heme) 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 to individuals from diverse backgrounds.
Contribute to the development and implementation of innovative modeling and simulation platforms/strategies to ensure the right drug is administered to the right patient at the right dosage.
Contribute to the preparation and presentation of internal and external documentation (e.g., Investigator’s Brochure, IND, CTD) and program strategy.