Associate Director Quantitative Data Modeling

Sanofi•Morristown, NJ

48d•Hybrid

About The Position

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Quantitative Pharmacology (QP) organization at Sanofi is dedicated to ensuring the safe and effective therapeutic treatment of patients by applying sound pharmacokinetic (PK) and pharmacodynamic (PD) principles to accelerate and optimize drug development. Within QP, the Pharmacometrics group employs Model-Informed Drug Discovery and Development (MIDD) approaches to support decision making throughout the drug development continuum. This includes guiding dose selection and study design, de-risking potential drug–drug interactions, quantifying benefit–risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle management. This position, based in Morristown, NJ, requires the successful candidate to be onsite three days per week. The Associate Director will play a key role in advancing Sanofi’s internal pipeline across multiple therapeutic areas by conducting a broad spectrum of model-based analyses, spanning population PK and PK/PD modeling, disease progression modeling, and advanced methodologies such as data analytics, machine learning, and mechanistic modeling. The incumbent will contribute to data-driven decision making and the application of innovative modeling strategies with minimal supervision. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Requirements

Strong quantitative skills including but not limited to mathematics, statistics, data science, AI/ML, etc.
Deep and extensive experience with advanced population modeling approaches (e.g. PPK, PKPD, etc. ) and complex methodologies such data analytic, AI/ML and mechanistic modeling.
Proficiency in conducting model-based analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, etc.)
Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
Strong written and verbal communication skills, interdisciplinary collaboration, problem scoping and planning.
Good knowledge of industry best practices, global regulatory, processes, standards of drug development.
Demonstrate the following scientific competencies:
Ph.D. with or without post-doctoral experience in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics, data science, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline plus at least 5 years of industrial experience with a record of increasing responsibility and independence
Technical expertise in several of the following areas ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, PUMAS, Matlab, PKsim, SimCYP, SAS, Python, C/C++, Julia
Excellent oral and written communication skills and strong problem-solving skills

Responsibilities

Ability to formulate drug development questions and develop modeling and simulation strategies for optimizing model-informed drug development in all stages of development, ranging from first in human dosing through life cycle management.
Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward.
Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed.
Serve as M&S representative for clinical development projects.
Act as a subject matter expert addressing technical and theoretical issues in the M&S area.
Be able to operate in a multicultural environment and participate in international teams.
Prepare and issue stand-alone M&S reports with minimal review.
Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA
Prepare abstracts, posters and manuscripts for external presentation and/or publication.
Present at external scientific meetings as appropriate
Identify skill-sets necessary to advance career development.
Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.

Benefits

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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