Scientific Director, Translational Quantitative Pharmacology (TQP)

EMD Serono Research & Development Institute•Billerica, MA

4d•$160,100 - $260,700•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 role involves working within cross-functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Pharmacometrics, Biostatistics, Data Sciences, Patient-Focused Real-World Evidence, Clinical Biomarkers and Diagnostics, Research, Clinical Development, and other colleagues within the R&D organization. The incumbent will participate in activities to strengthen the quantitative systems pharmacology (QSP) platform and fit for project capabilities by contributing to the strategic use of QSP and translational PKPD methodologies across disease areas, in alignment with the clinical development plan. There will be close engagement with all key stakeholders to ensure timely and high-quality pharmacometrics deliverables for the program. The incumbent will be responsible for translational modeling and simulation activities executed internally or in collaboration with external CROs and will provide close scientific and technical supervision. The incumbent will also be expected 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.
Position requires both 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 as well.
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

To be an independent contributor in the field of translational quantitative pharmacology and QSP and 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 quantitative systems pharmacology (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 quantitative systems toxicological (QST) 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.
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.