Medical Director

Job Summary:

The Senior Director will lead global and US-focused deliverables, within a matrix organization, consisting of colleagues within the medical affairs group. The Senior Director will represent medical affairs and ensures alignment working closely with research & development and commercial colleagues. He /she will also represent the company to external collaborators such as health care practitioners, research groups, payers, and alliance partners.

Key Responsibilities: 

• Develops and oversees the implementation of US and ex-US focused medical strategy and tactics for one asset, including scientific communications and publications, annual medical planning, field communications, and collaborations with experts
• Applies therapeutic/disease area expertise and clear business understanding to address current and future medical needs in clinical practice with medically appropriate use of investigational medicines.                                                 
• Oversees and provides hands-on support in the management, generation, and dissemination of clinical and non-clinical data that supports the medical strategy and results in high-quality publications.
• Leads a cross-functional team and continuously strives for alignment across the organization (and the alliance if applicable).
• Acts as standing or ad-hoc member for various cross-functional and cross-alliance teams; provide scientific/medical perspectives to the global and US strategic and medical organizations.
• Co-leads the formation, refinement, and execution of a robust Phase III plan
• Supports the design, conduct, oversight, analysis, and reporting of Medical Affairs clinical trials. Ensures timely submission and delivery of high-quality clinical trial documentation, implementation, and execution.
• Continues to develop and cultivate long-term strategic partnerships with clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders representing Regeneron.
• Establishes priorities for support of investigator-initiated studies
• Ensures accuracy of training material for scientific and product information
• Oversees medical review and approval of all promotional materials.
• Ensures goals and objectives are met and projects completed on time to high standards and within budget.
• Is responsible for optimal medical affairs resource allocation across the spectrum of a product’s life cycle.
• Oversees development and forecasting of project budgets across assets.
• Champions high standards of compliance, ethics, and patient safety putting patients at the center of all actions.
• Performs medical monitoring of post-registrational trails and is the signatory of documents related to the interpretation of patient-level data where necessary, if in possession of a medical degree 
• Interacts internally and externally with senior management and functional heads  

Requirements:

• Advanced degree MD, with a strong preference for a focus in neurology
• 12+ years of related industry experience, 5+ in medical affairs required.
• Solid background and experience in drug development and life-cycle development of related products required.
• Specialized knowledge: Neurology required.
• Ability to lead business and technical discussions internally and externally and explain scientific/medical concepts to all levels.
• Ability to cultivate and maintain relationships with key opinion leaders in the relevant fields.
• Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key opinion leaders
• Strong leadership and management skills.
• Attention to detail in analyses, deliverables, and communications.
• Strong presentation and communication skills; must be able to provide succinct, strategic, and actionable insights to senior management.
• Ability to juggle multiple projects.
• Thorough understanding of the healthcare environment including all external stakeholders