Medical Director, Medical Affairs

Overview

The Medical Director, Medical Affairs will serve as a strategic and scientific expert within the organization, providing medical leadership to support the development and execution of medical affairs strategies. This role involves cross-functional collaboration with clinical development, regulatory affairs, commercial, and market access teams to ensure that scientific data is effectively communicated and leveraged to optimize patient outcomes.

Responsibilities

• Medical Strategy and Leadership
• Develop and execute the medical affairs strategy to support the company's portfolio.
• Serve as the internal medical expert for therapeutic areas, providing strategic input to commercial, regulatory, and R&D teams.
• Identify and address medical and scientific gaps within the marketplace.
• Scientific Communication and Data Generation
• Provide medical and scientific oversight for publications, presentations, and medical education materials.
• Support the development and execution of real-world evidence and post-marketing studies.
• Review and approve scientific content as part of the MLR team to ensure accuracy, compliance, and alignment with company objectives.
• 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.
• External Engagement and Thought Leadership
• Build and maintain relationships with key opinion leaders (KOLs), healthcare providers, and academic institutions.
• Represent the company at scientific conferences, advisory boards, and medical meetings.
• Provide medical input and strategic guidance into investigator-initiated studies and research collaborations
• Work in conjunction with IST operations and Field Medical to ensure timely and successful execution of ISTs
• Cross-Functional Collaboration
• Partner with commercial and market access teams to provide medical insights that inform strategic decision-making.
• Work with regulatory and compliance teams to ensure adherence to industry standards and guidelines.
• Support internal training programs for medical science liaisons (MSLs) and commercial teams.

Qualifications

• Advanced degree (MD, DO) is strongly preferred; completion of residency and/or fellowship is desirable.
• • 5+ years of industry experience with relevant experience in the therapeutic area of interest preferred
  • Patient care clinical experience in the therapeutic area (including sub-specialty) preferred
  • Ability to efficiently manage time and priorities
  • Ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction
  • Strong knowledge of clinical development, regulatory requirements, and compliance standards
  • Ability to work cross-functionally and influence decision-making at multiple levels
  • Solid understanding of drug development and life-cycle development of a product
  • Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders; the ability to work effectively with key decision makers, both within and outside the Company
  • Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building
  • Ability to understand and translate external customer and/or internal client needs into effective decisions and to drive results and strive for continuous improvement with high performance in the face of adversity a must
  • Willingness to travel