Manager, Modeling and Simulation, PKDM US

Job title: Manager, Modeling and Simulation, PKDM US

• Grade: L3-1
• Hiring Manager: Malidi Ahamadi
• Location: Morristown, NJ

About the Job

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.

Main 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.

About You

Basic qualifications:

• 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.

Why Choose Us

• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$122,250.00 - $203,750.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.