COMPLETE Manager, Pharmacokinetics, Dynamics and Metabolism - Cambridge

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 at Sanofi is seeking a dynamic individual to serve as a PK/PD expert participating in multidisciplinary teams for clinical phase development projects mainly in oncology/immuno-oncology areas. This position will be based in Cambridge, MA

Job Details:

• Provide input to project strategy under supervision 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

• Review and/or develop protocols, analysis plans, and study reports for nonclinical PK/ADME and clinical pharmacology studies

• Review and/or conduct PK and PK/PD analysis

• Provide input to (and participate in) regulatory interactions at key milestones Construct PK/PD/Clinical Pharmacology components of regulatory documents and rapid resolution of regulatory matters

Minimum requirements:

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

• Minimum 3 years of experience in clinical PK/PD, pharmacometrics, and/or clinical pharmacology

• Hand-on experience with PBPK, population PK and/or PK/PD modeling

Preferred requirements:

• Strong 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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