Sanofi Group Director, Pharmacokinetics/Pharmacodynamics (PK/PD) in Bridgewater, New Jersey

The Pharmacokinetics, Dynamics, and Metabolism (PKDM) department at Sanofi contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process, where possible. PKDM generates, integrates, and leverages clinical and non-clinical PK, PK/PD and metabolism knowledge to support critical decision making and risk management for projects from first in human dosing through life cycle management. As such, we aid in dose selection/study design, de-risking of drug-drug interactions, benefit/risk assessment, and formulation development, with the use of Population PK, PK/PD, and PBPK approaches as appropriate, and contribute to regulatory submissions/interactions.

Job Summary:

PKDM is seeking an individual to lead a team of PK/PD experts participating in multidisciplinary teams for clinical phase development projects in multiple therapeutic areas as well as directly serve as a PK/PD expert on high priority projects. This position will be based in Bridgewater, NJ

Job Details:

  • Providing input to project strategy from first-in-human through life cycle management phases for dose selection/study design, de-risking of drug-drug interactions, benefit/risk assessment, and formulation development

  • Reviewing and/or developing protocols, analysis plans, and study reports

  • Reviewing and/or conducting PK and PK/PD analysis

  • Providing input to (and participating in) regulatory interactions at key milestones

  • Constructing/delivery of PK/PD/Clinical Pharmacology components of regulatory documents and rapid resolution of regulatory matters

  • Providing input into the development of global department strategies and issue resolution for drug development with novel therapeutic constructs

  • As appropriate, leading or participating in global departmental and/or cross functional teams focused on improving speed and efficiency of drug development

  • Provide input into resourcing strategies (both internal and external) focused on addressing project strategies

  • Leveraging specific scientific interests with the focus to become a global resource for issue resolution and strategy development

Minimum requirements:

  • PhD in pharmacokinetics, pharmacometrics, clinical pharmacology, or other suitable post-graduate qualification

  • Minimum of 12 years of industry experience in clinical PK/PD, pharmacometrics, and/or clinical pharmacology

Preferred requirements:

  • Experience with management of teams either directly or in a matrix environment

  • Experience in direct contribution to high profile regulatory meetings

  • Excellent written and verbal communication skills

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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