US Medical Director, Dupilumab Atopic Dermatitis

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* Job Title:

** US Medical Director, Dupilumab Atopic Dermatitis
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* Location:

** Cambridge, MA / Morristown, NJ
** About the Job
** Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

Sanofi is recruiting a Director, US Medical Affairs. The Director will report to the Head of US Medical Affairs, Dermatology. This position is based in Cambridge, MA (preferred) or Morristown, NJ. The role functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy, including scientific evidence generation and scientific information exchange with all key stakeholders.  

Essential to success is an outstanding partnership with the field medical team, Clinical Development, and Commercial to maximize the value proposition.  Externally, the role assists health care professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions.  
** About Sanofi:
** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
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* Main Responsibilities:

** A summary of responsibilities include:
* Support the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs)) and annual budget for assigned brand(s).
* Execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables.
* Communicate the details and progress of the Medical Plan to Management, the Core Team and all parties responsible for execution.
* Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/projects.
* Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.
* Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.  Partner effectively with commercial organization to develop appropriate and scientifically rigorous promotional material.
* Provide medical and scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
* Provide medical review of applications for independent medical education grants
* Provide medical review of training materials for medical and commercial employees
* Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR).
* Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
* Review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s).
* Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals.
* Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) and relevant professional societies within pertinent medical community to represent Sanofi and strengthen its reputation in the therapeutic area.
* Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings,…