Manager, Modeling and Simulation, PKDM US

Sanofi • Morristown, NJ

1d • Hybrid

About The Position

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 successful candidate will play a key role in advancing Sanofi’s internal pipeline across multiple therapeutic areas by conducting a broad spectrum of model-based analyses, specifically population PK and PK/PD modeling.

Requirements

• Ph.D. with or without post-doctoral experience in pharmacometrics, pharmaceutical sciences, clinical pharmacology, mathematics, statistics, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline
• Technical expertise in several of the following areas: translational and population PK and PK/PD modeling and simulation, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, time-to-event modeling, survival analysis, machine learning.
• Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, ADPAT, Matlab, PKsim, SimCYP, SAS, Python, C/C++, Julia.
• Excellent oral and written communication skills and strong problem-solving skills.

Responsibilities

• Develop the following scientific skills: Perform population PK modeling, mechanistic PK/PD modeling, exposure-response analysis, clinical trial simulation, and/or other model-based analyses such as disease modeling, survival analysis, and time to event analysis.
• Understand the strategic elements of drug development.
• Demonstrate the following scientific competencies: Serve as M&S representative for clinical development projects.
• Recommend a course of action to solve M&S issues.
• Act as a resource to address technical and theoretical issues in the M&S area.
• Be able to operate in a multicultural environment and participate in international teams.
• Prepare analysis plans and/or protocols.
• Prepare and issue stand-alone M&S reports.
• Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA.
• Can represent Sanofi to regulatory agencies.
• Prepare abstracts, posters and manuscripts for external presentation and/or publication.
• Present at external scientific meetings as appropriate.
• 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:
• Demonstrate excellent leadership.
• Possess excellent interpersonal communications skills commensurate with working in a multicultural organization.
• Independently accountable for meeting project timelines.

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.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree