Sanofi Group Manager Pharmacokinetics, Dynamics & Metabolism in Bridgewater, New Jersey

Support project teams as a modeling and simulation (M&S) and/or pharmacokinetics, dynamics, and metabolism (PKDM) expert

  • Conduct PK, population PK, PK/PD analysis, clinical trial simulation, and/or PBPK analysis

  • Formulate and execute PK/PD and M&S strategies for specific projects

  • Develop and review protocols, analysis plans, and study reports for M&S aspects

  • Prepare IB/IMPD/IND and other regulatory documents, when needed

Knowledge and Skills

  1. Develop the following scientific skills:
  • Perform population PK and PK/PD analysis, clinical trial simulation, and/or PBPK analysis under minimal supervision

  • Perform compartmental PK analysis and simulation

  • Perform complex non-compartmental PK analysis

  • Apply a logical and structured approach to file management

  • Accurately and fully record pharmacokinetic analyses in an auditable manner consistent with GLP practices, where applicable

  • Develop departmental procedures (SOP’s, Protocols, Safety Procedures)

  • May train/mentor others

  1. Demonstrate the following scientific competencies:
  • Serve as PKDM representative for projects, especially in the area of M&S

  • May recommend a course of action to solve M&S issues

  • Can 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

  • Understand the general scientific basis of protocols and overall study objectives as related to assigned studies.

  • Participate in the preparation of protocols and/or analysis plans

  • Prepare and issue preliminary notes, key results summaries, CSR sections, and stand-alone M&S reports with minimal review

  • Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA

  • Can represent Sanofi to regulatory agencies

  • Participate and/or present at departmental, external and international meetings within the company

  • Prepare abstracts, posters and manuscripts for presentation and/or publication

  • Present at external scientific meetings as appropriate

  • Identify skill-sets necessary to advance career development

  1. 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.
  • Possess excellent interpersonal communications skills commensurate with working in a multicultural organization

  • Demonstrate a proficiency at scheduling multiple activities

  • Monitor compliance with any appropriate Sanofi guidelines

  • Independently accountable for meeting project timelines

Formal education and experience required:

  • Technical expertise in several of the following areas: population PK and PK/PD modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling, and

  • Ph.D. with or without post-doctoral experience in a biological, chemical, mathematical, computer science or closely related discipline plus at least 4 years of relevant experience

or

  • Equivalent theoretical and technical knowledge.

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.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life