Sanofi Group Director Pharmacokinetics and Modeling and Simulation- Waltham/MA in Waltham, Massachusetts
Director of Pharmacokinetics
Sanofi is seeking a Director to lead the Pharmacokinetics and Modeling and Simulation in the Drug Metabolism and Pharmacokinetics (DMPK) research platform of the North American Hub. As a member of the DMPK department within the Pharmacokinetics function, the individual will develop and lead a team of interdisciplinary scientists responsible for providing quantitative and model-based approaches to inform on lead candidate design and selection, translational preclinical PK/PD, and human dose & regimen predictions across a broad range of modalities encompassing both biotherapeutics and small molecules.
The successful incumbent is required to have a strong PK and PK/PD expertise to support project teams across multiple therapeutic areas including immunology, immuno-oncology, rare diseases, neurosciences, and rare blood disorders.
The scope of project responsibility will range from early discovery up to first in human clinical trials.
The ideal candidate will have a significant industry experience and a thorough understanding of PK/PD principles along with modeling and simulation approaches amenable to guide and inform on PK/PD strategy in preclinical drug discovery.
The individual will also have the opportunity to represent DMPK on research projects to ensure effective integration of PK and PKPD into the team strategy.
In this role he/she will contribute to the project team strategy at the early discovery phase up to first in human trials.
In this role the individual will also be involved in preparation of IND/IMPD/CTX and other summary documents for regulatory submission.
Master's Degree in Pharmacokinetics, Biomedical/Chemical Engineering, Pharmacometrics or related discipline with at least 10 years industry experience.
Expertise in the application of Phoenix WinNonlin is required.
A Ph.D. in Pharmacokinetics, Biomedical/Chemical Engineering, Pharmacometrics or related discipline with at least 10 years industry experience.
Ability to design and implement PK/PD, and physiology-based modeling approaches to support first in human clinical trials for small molecules and biotherapeutics.
Ability to design, analyze and interpret quantitative pharmacology and pharmacokinetic data for effective communication of results to team and management
Expertise in the application of Phoenix WinNonlin is required, as well as experience with other modeling programs such as NONMEM, R, Monolix, Berkely Madonna, Matlab, etc.
Prior experience on data mining and artificial intelligence approaches is a plus.
Demonstrated ability to thrive in a matrix environment and in a global environment is a plus.
Strong written, presentation and verbal communication skills are essential.
Demonstrated ability to manage PK and PK/PD scientists.
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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