Purpose:  

The Scientific Director provides medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); education initiatives (medical education, data, society guidelines, and value proposition); safeguarding patient safety (risk minimization and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation and product launches) and market access. Collaborates with clin8ical development on Medical Affairs support of priority trials. 

Responsibilities:  

• With oversight, contributes to the development of brand strategies. Actively contributes to thee development of a TA EE Engagement Plan.  

• Leads and supports Medical Affairs initiatives for the target indication. 

• Develops and executes Medical affairs support of priority clinical development trials. 

• Contributes to the development of and leads the execution of Medical Education / Advisory Boards as needed; Lead conference planning and execution. 

• Generates clinical and scientific data per evidence gap assessment. 

• Responsible to manage budget for assigned projects. 

• Aligns Medical education and scientific initiatives with the Scientific Communication Platform. Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IIS submissions. 

• Contributes to the generation of Medical Information communication content and supports training on Medical Information materials.  

• Participates in design and execution of clinical trial safety, product safety and risk management plans. Track Risk Mitigation Plan (RMP) implementation.  

• Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.