Purpose:
The Scientific Director, Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.
Responsibilities:
•Develops and executes on US-GAMA FAS TA annual strategy in collaboration with Global TA Head and Head of US GAMA.
Proactively initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
•Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
•Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. As the Study Lead, is responsible for oversight of study enrollment and overall timelines for key deliverables.
•Provides in-house clinical expertise for the assets and disease/condition, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes partnering with Discovery colleagues on the design and implementation of translational strategies.
•Acts as a clinical interface and actively solicits opinion through leader interactions related to clinical assets and disease/conditions; partners with Field Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
•May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of medical affairs sponsored or supported clinical research activities.
•May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
•Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease/condition specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
•Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
