Title: Director, Medical Affairs
The Director of Medical Affairs is a leadership role that provides medical and scientific leadership for Medical Affairs. This position will have multi-faceted responsibilities and accountability. This position will work with the Head of Medical Affairs in the activities associated with the development and commercialization of new products, if any, and the support of existing products, including bringing strategic marketing input to the clinical team and clinical input to the marketing team. The incumbent will act as a driving force in the public dissemination of information and data, including on and off label information, as well as promotional materials. In conjunction with the Head of Medical Affairs, the Director will provide a medical resource to the various Marketing and Sales Departments, as needed.
Essential Duties and Responsibilities
Education Requirements and Qualifications
- Act as a medical and scientific advisor regarding approved products and marketed unapproved products, as assigned by the Head of Medical affairs.
- Provide strong technical and medical expertise to execute on defined strategies.
- Be the subject matter expert and develop, review, and provide scientific information regarding on- and off-label use of company products as requested by health care providers.
- Respond to unsolicited drug information inquiries from customers and healthcare professionals.
- Under the guidance of Head of Medical Affairs, build a Medical Affairs plan with specific medical tactics, in partnership with other medical functions and aligned with the medical strategies. Provide medical and scientific support and assist in the training of the Marketing and Sales business units.
- Review educational programs, inclusive of Continuing Medical Education grant requests, from vendors and health care professionals for merit and support.
- Assist the Head of Medical Affairs with focused assignments for design, execution, and summary findings of Scientific Advisory Boards and Phase IV studies.
- Establish and maintain relationships with key scientific consultants and health care professionals.
- Identify, contact, develop and maintain relations with health care professionals to establish and/or further the knowledge of products and their appropriate use; when necessary, assist in resolving issues pertaining to that use.
- Develop and coordinate relationships with external research foundations.
- Provide input into the creation of educational programs, symposia, and marketing materials to ensure accurate and effective communication of data. Review and approve marketing materials for accuracy and fair balance.
- Develop onboarding and continued training programs for Medical Affairs staff
- Identify key clinical meetings on local, state, and national levels for attendance by one or more members of the Medical Affairs team.
- Assist, as assigned by the Head of Medical Affairs, with publication strategies inclusive of manuscripts, presentations, international symposia, and posters.
- Contribute to and support execution of the lifecycle management activities for the company’s commercialized indications/assets.
- Assist other Medical Affairs managers, when required, with various projects and responsibilities.
- Training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) expertise.
- MD, PhD, or Pharm.D. and a minimum of 10 years pharmaceutical industry experience required, Including managing a Medical Affairs Team.
- Minimum of 5 years Medical Affairs experience
- Scientific background and solid understanding of the pre-clinical and clinical development processes.
- Demonstrated understanding of legal, regulatory and compliance policies
- Statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.
- Ability to work well in a matrix environment, particularly with Clinical Research & Development, Project Management, Regulatory Affairs, Sales, Medical Marketing.
- Flexibility in adapting to multiple therapeutic areas interchangeably.
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Travel up to 20% of the time.