Medical Advisor, North America CSU

Job description

The Medical Advisor role with Sanofi provides an excellent opportunity to apply your clinical and drug development knowledge to deliver industry leading phase I to IV clinical trials. This role provides a very unique combination of scientific knowledge and operational details with the ultimate goal of providing innovative and cutting edge options for health care providers and patients. Medical Advisors within the NA Clinical Study Unit (CSU) work closely with a highly skilled Operations team and fellow Medical Advisors across different therapeutic areas. Outside of the CSU, Medical Advisors work closely with Physicians and Scientists across different sanofi units and departments. This role also offers an opportunity to work closely with Physician Investigators and Thought Leaders in your therapeutic expertise.     

Medical Advisor is responsible for successful implementation and operational aspects of Phase I to IV clinical studies. Direct/lead the Team to ensure successful completion of US and Canada Phase I– IV clinical trials in a timely, ethical, and a scientifically responsible fashion.

·  Evaluate feasibility of, and direct a program of Phase I to 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.
·  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. Identification and evaluation of investigators. Medical representative responsibilities: SAE, narrative summaries; active collaboration with the corresponding clinical operations department; presentation of the trial, presentation of trial results, provide answers to questions of a medical nature; participation in important congresses or events concerning the therapeutic field.
·  Presentation of the trial results and provide answers to questions of a medical nature. Participation 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 and Canadian regulations

PRINCIPAL DUTIES AND RESPONSIBILITIES:

·  Evaluation of 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.
·  Maintaining 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, presentation of trial results, provide answers to questions of a medical nature. Participation 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 and reportees.

REQUIREMENTS:

Knowledge And Skills:

This position requires an individual with a strong understanding of medical practice as well as the scientific research process.  Strong verbal and written skills are required to complement the ability to analyze and develop recommendations that affect the conduct of studies and the content of regulatory submissions.  Knowledge of, and experience with, the process of data collection, data management, and data analysis are required. Good negotiation and persuasion skills are important. The ability to interpret clinical data accurately is essential.  Eagerness to commit to the completion of tasks within an aggressive but realistic time frame is essential. Ability to function in a transatlantic pharmaceutical research environment is essential.

Formal Education And Experience Required:

Medical degree; Board Certification or Board Eligibility in Internal medicine and/or endocrinology is preferred.  

3+ years of Clinical experience with at least 2 years Clinical Research experience;

Demonstrated skills in communication (written and personal) and personal interaction; Demonstrated skills in effective medical writing and review. 

Experience in a global research setting is preferred.

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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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.