The Regional Medical Director will support US Medical Affairs in order to execute the consolidated US Medical Affairs strategy; ensure accurate, robust and appropriate medical/scientific exchange of knowledge and clinical expertise with US stakeholders for AVXS-101; provide geneticist subject matter expertise; and partner to the business in driving success.
Responsible for executing the company’s US Medical Affairs strategies/tactics for SMA.
Coordinates regional Medical Affairs tactics within the US Medical Affairs organization.
Partners with Clinical Development and Commercial function in developing and implementing US medical strategies for appropriate lifecycle management.
Maintains in-depth understanding (scientific and clinical) of the disease state, product, competitors, marketplace, related medical areas and regulatory guidelines.
Responds to requests for clinical data appropriately per guidance from AveXis leadership
Develops the strategy for field Medical activities and Key Opinion Leader (KOL) advocacy plans to build and maintain critical relationships and knowledge management.
Collaborates with Medical Information other RMDs to assure that medical information materials are up to date, accurate, balanced and useful to stakeholders.
Develops and delivers scientific presentations to internal and external audiences (commercial, healthcare professionals, consumers, organizations, etc.).
Acts as the primary resource to healthcare providers who request information on AveXis products, ensuring accurate and appropriate responses.
Plans and develops programs and participates in medical congresses, expert meetings and other medical activities.
Contributes to US publication planning function in collaboration with the Global publication plan to drive the scientific agenda.
Leads the planning and execution of scientific Advisory Board meetings.
Leverages scientific knowledge and KOL relationships to identify opportunities for activities leading to scientific advancement.
Sets the strategy for investigator-initiated research studies, and evaluating and recommending medical/therapeutic concepts.
Collaborates with internal Patient Advocacy relations to function as primary contact for national patient and disease state associations and organizations.
Provides medical input into Health Economics and Outcomes Research (HEOR), disease models, epidemiological studies, market research and real-world study proposals.
Maintains budget responsibility for all US medical activities.
Experience in Medical Affairs (ideally as an MSL and preferably in the biotech industry) would be impactful. Experience managing MSLs preferred.
Experience with Payer organizations preferred, especially real-world experience with neurologists and neuro-genetic disorders.
Excellent written and oral communication skills, including strong formal presentation skills.
Excellent planning and organization skills.
Strong interpersonal skills commensurate with the need to work closely with both external physicians/scientists and numerous in-house support groups.
Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism.
Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants.
High proficiency in problem solving ability and strong scientific analytical skills.
Willingness/Ability to travel up to 40% and internationally at times is required.
AveXis is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial proprietary gene therapy candidate, AVXS-101, is currently in an ongoing Phase 1 clinical trial for the treatment of SMA Type 1.