The Associate Director, US Medical Affairs will play a key role in the Cell Therapy and Regenerative Medicine (CTRM) clinical and commercial development of marketed and soon to be marketed products, through activities related to publications, investigator and company sponsored trials, professional education, KOL and thought leader outreach and development, major Association relationships, advisory boards, speaker bureau training and evaluation, interacting with payors and guideline developers and providing general medical guidance and support for commercial activities and teams. The primary goals of the Associate Director / Director, Medical Affairs, CTRM, are to build awareness of CTRM products in the medical community and maximize patient and clinician benefit from these products through ensuring their safe and appropriate use. The position is contained within the CTRM Business Unit and reports to the Director Medical Affairs, CTRM.? It is expected that the successful candidate will work closely with the CTRM business unit, the MSL Director and head of US advocacy, Ex-US MSLs and medical team, head of strategic and life-cycle planning, and General Manager.
Participate in the development of strategic publication plans and tactics; attend publication planning team meetings.
Attend and contribute to the selection, development and approval of clinical studies (ISS and company sponsored)
Along with the MSL team work with investigators to ensure the smooth running of clinical trials including the close-out and timely reporting.
Provide support and oversight for the preparation high quality publications and presentations and other written communication material (Posters, position papers, teaching material).
Manage relevant external resources to meet objectives in a cost-efficient and timely manner, effectively using project management skills.
Work closely with lead external authors and assure that their primary responsibility for content adheres to ICJME standards.
Provide support and assistance in the training of field based MSL teams locally and internationally.
Identify, develop, and maintain partnering relationships with current and future thought leaders, KOLS and association leaders together with head of Advocacy
Foster scientific and clinical information exchange between medical community and Sanofi Biosurgery
Drive internal and external communication strategies for state-of-the-art disease
information and clinical messaging
Liaise with internal and external contributors, including authors & key health care decision makers on a variety of projects
Ensure that strategically aligned scientific communication points are delivered and that statements and conclusions are accurate and supported by appropriate data.
Provide scientific support for field sales efforts in providing the scientific and clinical information necessary in order to improve patient care in addition to providing support and review of all external communication material.
Provide support for speaker development and evaluation together with MSL teams.
Provide medical support at relevant professional congresses and contribute to the collection of competitive intelligence.
Provide scientific support for formulary and clinical guidelines decision makers including assisting in the development of materials necessary for HEOR value dossiers
Medical Degree, PHD or Pharm D degree in life sciences.
5 or more years of pharmaceutical and/or biotech industry experience in a medical department role.
Demonstrable evidence of a successful career in medical affairs, medical liaison, training, clinical research associate or similar role
Solid understanding of manuscript-writing processes for publication in peer-reviewed journals, including familiarity with external clinical publication practices and standards (e.g. ICMJE, AMA, CONSORT).
Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
Excellent data interpretation and presentation skills.
Thorough understanding of the clinical drug development process.
Demonstrated ability to manage several projects simultaneously.
Demonstrated ability to make effective decisions even in the absence of complete information and when under pressure.
Advanced medical or surgical degree
Experience with cell therapy or regenerative medicine disciplines
Orthopaedic or relevant surgical experience
Excellent writing and editing skills, including a clear, concise scientific style with attention to detail and the ability to write concise summaries of complex issues.
Ability to think strategically.
Excellent interpersonal skills, matrix management, negotiation, and leadership skills.
State or Province