Vice President of Medical Affairs

NOTE: MD and either Board certified or Board eligible are required

Reporting to the CEO, the Vice President/Senior Vice President of Medical Affairs will be responsible for designing the Medical Affairs strategy and continuing to build out the Medical Affairs function, including HEOR, Strategy and Operations, Field Medical Affairs, Medical Communications, and Patient Advocacy. This role will require a hands-on approach within a currently-lean organization. This individual will cultivate strategic and tactical plans to support the development and preparation for the launch of the company’s products. S/He will partner externally, both virtually and face-to-face, with key opinion leaders and healthcare professionals to optimize patient care and treatment outcomes through compliant and evidence-based decisions. 

Some responsibilities:

• Lead the Medical Affairs function to achieve corporate goals while keeping in compliance with policies and regulations to support patient care and access.
• Direct study design and execution for Medical Affairs studies including both early and later phase studies and programs, and execute life cycle management plans. 
• Engage in the review and approval of investigator-initiated and sponsored research strategies and review processes.
• Champion and lead the development of strategic Medical Affairs launch plans, training materials, and medical information to provide scientific and medical support for publications and presentations. Oversee speaker programs on disease state, current therapeutics, and patient care gaps.
• Provide strategic direction to the Executive Leadership Team on all Medical Affairs matters.
• Work closely with the Commercial and senior management teams to develop a compelling overall strategic vision, evaluate alternative strategies, capitalize on core strengths, and implement operating plans to achieve objectives for growth. Ensure timely, accurate, and compliant preparation and review of promotional and educational materials.
• Represent the company at global scientific congresses, professional society meetings and patient advocacy forums. Proven capability of communicating research platforms and targeted approach to drug development to relevant audiences. 

Some requirements:

• MD and either Board certified or Board eligible
• 15+ years of progressive leadership experience with Medical Affairs within pharmaceuticals or biotechnology
• Experience with gastroenterology, immunology, rheumatology, internal medicine, or dermatology required
• Experience with biosimilars sales is preferred
• Expert skills in building relationships and experience networking with Key Opinion Leaders required
• Extensive experience in drug development, commercialization of drugs and direct interaction with regulatory agency guidelines and practices. Such as good clinical practices (GCP), FDA regulations and guidelines, new drug commercialization and business practices, resourcing and budgeting, and the ability to negotiate with these groups
• Highly effective verbal and written communication skills

SORRY, NO VISA SPONSORSHIP, NO THIRD PARTY AGENCIES