Associate Director, Translational Quantitative Pharmacology (TQP)

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 142,000 - 215,000; Full time

Job summary

EMD Serono, Inc. is seeking an Associate Director of Translational Quantitative Pharmacology to drive Model Informed Drug Development across Oncology and Immunology pipelines.

You will develop and execute QSP platform models and collaborate with CROs as needed, mentoring junior scientists and guiding project teams. The role reports to the Global Head of Translational Quantitative Pharmacology and is based in a hybrid office setting in Massachusetts, requiring up to 20% travel.

Qualifications

• PhD in Pharmacokinetics or related field required.
• Minimum 5 years in industry and/or academia applying modeling and simulation to biology.
• Willingness to travel up to 20% (domestic and international).

Responsibilities

• Develop and execute MIDD strategies including quantitative systems pharmacology models across R&D lifecycle.
• Supervise internal and external TQP work and manage multiple projects.
• Communicate modeling results to cross-functional teams and develop modeling toolboxes.

Skills

QSP modeling

Pharmacokinetic modeling

MATLAB/SimBiology

NONMEM

R

Monolix

PBPK modeling

Mentoring

Education

PhD in Pharmacokinetics

Tools

MATLAB/SimBiology

NONMEM

R

Monolix

Simcyp

GastroPlus

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

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.

Location

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

Key Accountabilities

• 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.

Who You Are

Minimum Qualifications

• 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

Preferred Qualifications

• 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
• 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.

Pay Range for this position: $142,000 - 215,200

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!