Sanofi Group Medical Advisor NA CSU in Bridgewater, New Jersey

The Medical Advisor is responsible for successful implementation and operational aspects of Phase I to IV clinical studies. They will direct/lead the Team to ensure successful completion of US Phase I, II, III and IV clinical trials in a timely, ethical, and a scientifically responsible fashion. They will also evaluate feasibility of, and direct a program of Phase I-IV clinical research involving products leading to the filing of an NDA. This entails reviewing protocols and supervising the conduct of clinical studies in adherence of Sanofi SOPs, as well as institutional and governmental regulations in the United States and Canada. In addition, they will ensure training of NA CSU team regarding the product, the pathology, the regulatory environment, the protocol and the CRF. Maintain a network of experts and potential investigators within his/her therapeutic field. They will actively collaborate with the corresponding Medical operations department; provide the presentation of the trial and trial results, provide answers to questions of a medical nature; participate in important congresses or events concerning the therapeutic field.

Responsibilities:

  • Evaluate the feasibility in his/her country of clinical trials proposed by Sanofi: Evaluate the synopsis; collect information and documentation concerning the proposed study that will help determine its feasibility and provide support for the eventual go/no-go decision; formalization of a commitment to objectives set, in terms of number of patients and investigating centers and delays for study conduct.

  • Maintain a network of experts and potential investigators within his/her therapeutic field; identify potential investigator's site competence and their capacity to respect the trial commitments; approve site selection.

  • Direct/lead the Team that is conducting US Phase I, II and III clinical trials in a timely, ethical, and a scientifically responsible fashion.

  • Presentation of the trial and trial results, provide answers to questions of a medical nature. Participate in important congresses or events concerning the therapeutic field. Serve as a medical monitor for these trials and be responsible for the ongoing review of these trials and of the projects as regards US regulations in particular.

  • Review SAE, narrative summaries, interact with the pharmacovigilance department to ensure that serious adverse events, involving this US clinical development, are followed up, evaluated, reported to regulatory authorities (FDA) and notified to US Investigators promptly

  • Ensure that all activities under his/her direction comply with Sanofi Clinical Development Standard Operating Procedures (SOP's), Good Clinical Practice and US Regulations.

  • Provide appropriate mentoring on the drug development process, and provide assistance with the career development of team members.

Required Education/Experience

  • Ph. D or Pharm. D. with 5+ years of experience in Pharmaceutical Industry (preferably in Medical Affairs). In case of a Ph. D. or Pharm. D Medical Advisor, physician back up will be available to address any Clinical Care questions.

  • Demonstrated excellence in written and verbal communication and personal interaction

  • Demonstrated skills in effective protocol review and proposing appropriate modifications.

Preferred Education/Experience

  • Medical degree; Board Certification or Board Eligibility in Internal Medicine and/or Endocrinology with 3+ years of Clinical experience with at least 2 years Clinical Research experience

  • Ability to interact in a global research setting

Sanofi US Services, 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