Offers “Sanofi”

Expires soon Sanofi

Principal Scientist, Pharmacokinetics- Waltham/MA

  • Waltham (Lincolnshire)
  • Marketing

Job description



Job Summary

Sanofi is seeking an experienced project leader to join the Drug Metabolism and Pharmacokinetics (DMPK) research platform of the North American Hub. As a member of the DMPK department the individual will be an integral project team member representing DMPK on biotherapeutics research projects to ensure effective integration of PK and PKPD into the team strategy. This includes contributing to selecting appropriate clinical candidates, developing sound PK strategies, designing PK and PKPD studies, projecting human dose and regimen, and preparing IND/IMPD/CTX regulatory submissions.

This role will be responsible for analyzing and reporting of pharmacokinetic data across multiple modalities with a focus on biotherapeutic modalities. The successful incumbent will have expertise to support project teams across multiple therapeutic areas including ImmunoOncology/Oncology, Immunology/Inflammation, Rare Diseases, and Rare Blood Disorders. In this role he/she will contribute to the project team strategy at the early discovery phase up to first in human trials.

Requirements

·  A Ph.D. in Pharmacokinetics or related field with at least 5 years industry experience
·  Ability to design and implement preclinical pharmacokinetic and PKPD studies required to support first in human clinical trials
·  Expertise in the application of Phoenix WinNonlin is required and ability to analyze pharmacokinetics studies using NCA
·  Experience as a team member on interdisciplinary project teams is essential, with experience on biotherapeutic projects
·  Strong written, presentation and verbal communication skills are essential
·  Experience with IND/IMPK/CTX preparation and submission
·  Demonstrated ability to work in a matrix environment and experience working in a global environment is a plus

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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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.

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