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.
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
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
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
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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.
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