Sanofi Group Senior manager PK/PD in Bridgewater, New Jersey

Support TMED as a PKDM representative as follows

  • Develop and review protocols, analysis plans, and study reports

  • Conduct PK analysis

  • Prepare CIB/IMPD/IND and other regulatory document

  • Represent PKDM and formulate strategies for specific projects

Have a body of skills that include:

  • Perform complex non-compartmental PK analysis

  • Perform compartmental PK analysis and simulation

  • Perform PK/PD analysis

Perform PBPK analysis

  • Apply a logical and structured approach to file management

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

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

  • May train/mentor others

Demonstrate the following competencies:

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

  • Be able to operate in a multicultural environment and participate in international teams

  • Serve as PKDM representative for projects in areas of therapeutic expertise

  • Prepare and issue preliminary notes, key results summaries and CSR sections with minimal review when necessary

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

  • 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

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

  • Can represent Company to regulatory agencies

  • Will recommend a course of action to solve pharmacokinetic issues and may be responsible for its implementation

  • Able to lead development of new technologies

  • Can act as a resource to address technical and theoretical issues for the domain

  • 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

  • Demonstrate a proficiency at scheduling multiple activities

  • Monitor compliance with any appropriate Sanofi guidelines

  • Independently accountable for meeting project timelines

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

  • Be able to act as a Principal Investigator/Participating Scientist for the phases of nonclinical studies conducted in PKDM

Education and Experience Requirements:

  • Ph.D. in PK, PK/PD, or related field, with or without post-doctoral experience plus at least 3-6 years of relevant experience in clinical area, preferably in the pharmaceutical industry

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