Contract - Medical Director, Medical Affairs

CONTRACT - MEDICAL DIRECTOR, MEDICAL AFFAIRS

Position Summary:

The Contractor Medical Director, Medical Affairs will be a key member of the Medical Evidence team and will help set strategy for both internal Company programs and external facing interactions. The Contractor is responsible for the design and execution of Phase 3b/4 studies, Externally Sponsored Research Collaborations, Expanded Access Programs, and Product Registries. The Contractor will work closely with investigators and KOLs to ensure studies will address the needs of providers and patients. The Contractor will report directly to the ED, Medical Evidence.

Essential Duties and Responsibilities:

• Develop protocols and serve as medical monitor of Medical Affairs sponsored studies
• Coordinate with Company Outreach and Patient Advocacy Team on interactions with community advocates and patient support groups
• Design, execution, and interpretation of Phase 3b/4 studies, Expanded Access Protocols, product registries, and other sources of medical evidence in collaboration with internal colleagues, clinical centers, vendors, and other external partners. Lead development of study protocols, CRF design and database development, ICF/patient authorizations, site initiation and data entry activities and development of analysis plans. Support development of physician and patient engagement plans, including web portals, advisory boards, and novel tools to enable long-term data collection
• Partner with Patient Advocacy to develop studies to understand the patient and caregiver perspective around burden of disease and treatment outcomes
• Support the development of criteria and processes for Externally Sponsored Research (ESR) studies; collaborate with Field Medical Affairs and investigators to provide input on study design and budgets
• Collaborate with external study investigators, patient groups, and other consortia to maximize synergies in development of and access to complementary data-sets
• Collaborate with colleagues in Medical Affairs to ensure all communications are aligned with the medical strategy to facilitate patient access to treatments

Qualifications:

• M.D. or PhD degree is required
• Minimum of 9-14 years' experience in an academic or research institution or in industry
• Solid understanding of drug development and life-cycle development of a product
• Ability to function independently to progress key projects with minimal direction and oversight
• Demonstrated ability to work effectively in teams with a commitment to cross-functional risk sharing, collaboration and learning that facilitates partnership, collective accountability and prompt, informed decision-making
• Maintain clinical and technical expertise through review of the scientific literature and attendance at key scientific meetings
• Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building
• Demonstrated ability to deliver on commitments, to lead by example, and to enable others to effectively contribute