Summary of Position
The Vice President, Medical Affairs will be responsible for driving our internal medical strategies in a manner that considers the evolving healthcare ecosystem and the unmet needs of patients. This person will be responsible for overseeing the establishment of the Medical Affairs Department and providing strategic leadership for the development and execution of all Medical Affairs initiatives that will position MacroGenics externally as a leader in Oncology. This position involves both high level strategic planning, management of people, and hands-on execution of responsibilities.
Responsibilities and Job Duties:
• Establish and provide strategic leadership for MacroGenics’ US Medical Affairs organization; develop annual strategic plan in collaboration with other functions including Clinical Development, aligned with our US brand plans, and in compliance with corporate policies and regulatory requirements. Guide strategic direction for development and lifecycle management activities to ensure smooth transition from clinical development to commercialization.
• In collaboration with the Clinical Development team, establish a strategy for and execution of all non-registrational clinical research supporting commercialized products including Investigator Sponsored Trials (ISTs), observational research, cooperative group trials, registries and health economics and outcomes research.
• Establish necessary and appropriate internal policies and processes to build the Medical Affairs function to support the launch of the company’s first product into the oncology marketplace and to continue successful development of products in the pipeline. Build out a medical information process and systems to appropriately respond to questions and concerns about our products. Ensure that all individuals involved with process have a thorough understanding of the responsibilities and proper training for the role.
• Drive engagement with Key External Experts based on recognized thought leadership and expertise, strategic partnerships, and a clear focus on evidence generation to address unmet needs. This includes understanding current treatment practice realities and the key issues of the external healthcare community and being able to bring those insights to internal stakeholders to improve decisions around the development of MacroGenics products.
• Create best in class, credible, relevant and innovative communications about our clinical information for key stakeholders. Ensure that we have top quality scientific materials and publications that educate health care providers regarding the appropriate use of our products. Develop, maintain and execute our Scientific Communication Plan and Publication Strategy.
• Participate fully in the legal, regulatory and medical review of promotional materials to ensure that information shared externally is medically accurate and appropriate.
• Represent Medical Affairs function at various meetings with government agencies, medical meetings, advisory boards, symposia and outreach meetings, working appropriately with Commercial organization to optimize advocacy of products.
• Establishment of an engagement plan to share appropriate and relevant clinical and value information with market access stakeholders to ensure appropriate patient access for MacroGenics’ products at launch and throughout the product lifecycle. Provides appropriate Medical Affairs support for discussions with US payors and access stakeholders.
• Establish and lead a Medical Grant Review process and manage the allocated budget and timelines and ensure compliance with all requirements and regulations related to medical grants.
• Provide leadership to and oversees the selection, training and management of the Medical Affairs Team including the US field Medical Science Liaisons. Coach and mentor for highest level of performance, and conduct performance evaluations of Medical Science Liaison team via active observation against clearly defined team and individual goals & objectives (quantitative and qualitative).
Education & Credentials
M.D. with oncology expertise required
• A minimum of fourteen (14) years of professional level experience in pharma/biotech industry
• Five years of experience supervising, mentoring, coaching and leading field and HQ Medical Affairs teams
Knowledge, Skills and Abilities
• Strategic thinker who can provide vision and purpose for teams
• Must be able to collaborate with other functional owners to drive highest quality of decision making
• Strong strategic and analytical abilities
• Must have strong conceptual abilities and analytical skills
• Ability to make sound and timely decisions
• Excellent working knowledge of drug development process
• Effective influence and relationship management skills with internal and external partners
• Able to set priorities for team, establish clear direction and objectives and maintain accountability
• Able to balance scientific & business perspectives
• Demonstrated success in fostering an environment that brings out the best in people
• The ability to communicate both orally and in writing to a high standard, and handle group and individual presentations effectively
Field based team of Medical Science Liaisons
Other Medical Affairs staff to be determined
• Sub-specialty and board eligibility/certification in oncology
• Clinical research experience (phases I-III) in oncology
• Prior experience in late stage clinical trials focused on immune-oncology and antibody based product candidates a plus
• Clinical experience and academic track record in solid tumors or hematologic malignancies