Sanofi Group Director, Translational Medicine and Clinical Pharmacology- Bridgewater, NJ in Bridgewater, New Jersey

This position is in the global department responsible for Translational Medicine and Clinical Pharmacology across all of the therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, and nucleic acid modalities. This department is part of the TMED (Translational Medicine & Early Development) platform in R&D Operations. The individual in this position is an integral part of the cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical development including rapid Proof-of-Concept, as well as experimental medicine studies to evaluate the pharmacology of novel therapeutic approaches. Collaborative interactions with laboratory research scientists, toxicologists, pharmacokineticists, modeling and simulation experts, biomarker experts, and late phase therapeutic area clinicians are critical to success in the role. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine plan is essential.

At the project level, the individual will be a member of the translational medicine subteam. In these roles, duties include :

  • Participate in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the responsible Therapeutic Area.

  • Design and supervise the conduct of safe, rapid and informative First-In-Human studies, streamlined Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic and mechanistic studies.

  • Review, interpret results, and author translational medicine and clinical pharmacology-related clinical documentation, including: clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology components of investigator brochures, regulatory documents.

  • Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects.

  • Participates in the dose selection for first-in-human studies, Go/No Go decisions when needed.

  • Ensures an adequate follow-up of studies and project timelines.

  • Presents data in appropriate meetings (inside or outside the Group).

Major Challenges and opportunities:

  • Communication of the role of the department; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative attitude.

  • Takes an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.

  • Ensures Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.

  • Ensures high quality documents, requiring strong writing and communication skills.

  • Manages aggressive timelines effectively through cross-functional planning.

Key Internal/External Relationships:

  • Internal contacts: Clinical Pharmacology Operations (CPOP, including Clinical Trial Managers and Data Managers), Biostatistics, Preclinical Safety, Regulatory Affairs, Global Pharmacovigilance, Therapeutic Area Research and Development Groups.

  • External contacts: Investigators, early phase clinical research organizations, clinical trial vendors, clinical and scientific experts, ethics committees, health authority representatives.

Decision Making Authority:

  • Makes front-line decisions on protocol design, execution, dose escalation and safety, information for regulatory authorities.

At the clinical study level, the individual will also serve as Study Medical Manager for selected clinical studies. Study Medical Manager principal duties and responsibilities include :

Study preparation:

  • Designs, and conducts early clinical development studies within planned timelines (supported by an operational team).

  • Reviews and approves study documentation (case report forms, monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).

  • Coordinates clinical team to set-up and follow the study.

  • Ensures proper documentation is provided to the Ethics Committees and Health Authorities.

Study conduct:

  • Ensures that the study is scientifically sound and correctly conducted.

  • Prepares and reviews the interim investigator reports.

  • Provides documents for making decision to start next dose level (for First-in-Human studies).

  • Reviews the Serious Adverse Event reports.

Study validation and reporting:

  • Participates in the data review and validation meetings before database lock.

  • Reviews and interprets the results.

  • Prepares and distributes the Key Results Memo and prepares/reviews the Clinical Study Report.

Key Internal/External Relationships:

  • Internal contacts: Clinical Pharmacology Operations (CPOP, including Clinical Trial Managers and Data Managers), Biostatistics, Preclinical Safety, Regulatory Affairs, Global Pharmacovigilance, Therapeutic Area Research and Development Groups.

  • External contacts: Investigators, early phase clinical research organizations, clinical trial vendors, clinical and scientific experts, ethics committees, health authority representatives.

Basic Qualifications:

  • Advanced degree: M.D. or M.D./Ph.D., or PharmD or Ph.D degree in a health-related science with at least 1 year of research experience

Preferred Qualifications:

  • M.D. or M.D./Ph.D. strongly preferred

  • Postgraduate experience; laboratory research in industry or academia is a plus.

  • Broad biomedical knowledge base

  • Knowledge and mindset in translational research

  • Able to acquire and apply new technical skills

  • Experience in the conduct of clinical trials is preferred

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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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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life