The Role:

Reporting to the Chief Medical Officer, the VP, Head of Medical Affairs will build and lead this function at Nuvalent. This person will be responsible for establishing the Medical Affairs vision, overseeing the organizational build including cross-functional integration, developing strategies and supporting tactical execution for a wide array of sub-functions (Strategy and Operations, Field Medical Affairs, Medical Communications, Evidence Generation and HEOR, Patient Advocacy), interacting with senior leadership, and taking a “hands-on” approach in a lean organization.

This role will be a balance of cross-functional leadership, “do-it-yourself”, and managing a mix of to-be-hired direct reports and external consultants and vendors. The ideal candidate will have broad experience across multiple functions within Medical Affairs, a proven track record of successful launches in the US and Europe, and experience in oncology drug development.

Responsibilities:

• Create and implement a vision and strategy for the newly created Medical Affairs function.
• Ensure the development and execution of strategic and functional plans and facilitate processes to ensure all Medical Affairs programs and activities are aligned with business strategies and legal and regulatory guidelines.
• Collaborate with cross-functional teams to drive brand strategy, ensure alignment across teams, and provide compliant medical input.
• Build and provide leadership to key Medical Affairs sub-functions including Medical Communications, Medical Affairs Operations, and Field Medical Affairs.
• Provide oversight of, and content-expertise to, outsourced functions such as Medical Information, Evidence Generation, HEOR, and Expanded Access Programs.
• Establish and lead compliant thought-leader engagement strategies, including advisory boards and 1:1 external engagement; map and plan for an integrated approach to thought-leader engagement across Field Medical Affairs (when built) and with internal cross-functional teams.
• Oversee a Medical Communications lead/vendor charged with the development of impactful scientific and medical education for internal and external stakeholders, including publication and congress plans and medical/scientific content development, that is consistent with and complementary to corporate strategies.
• Oversee evidence generation planning, including HEOR strategy and tactics, to support market access efforts; lead data gap identification, data dissemination and active insight collecting.
• Represent Nuvalent at external meetings with stakeholders per medical strategy, including national and international oncology associations.
• Lead strategy and engagements with national and international advocacy organizations while maintaining the highest level of sensitivity, integrity, and compliance.
• Support the writing and updating of SOPs for Medical Affairs, ensuring compliance with all relevant external guidelines.
• Facilitate key processes including medical-legal-regulatory review, grant review, and investigator-initiated study review committees.
• Create a continuous learning environment that encourages internal team engagement and strong external partnerships.
• Conduct secondary research and present data on product/disease areas of interest as needed; serve as a key medical resource for the disease areas and specific products as part of business development activities.

Competencies:

• Prioritization of the patient and the patient community as the focus of our work.
• Excellent interpersonal skills with a demonstrated track record of achieving results and optimizing team performance.
• Strong business acumen with a proven ability to execute complex plans and manage budgets and resources responsibly.
• Ability to work independently and as part of a team with a strong sense of urgency.
• Adeptness at building collaborative relationships with internal and external stakeholders.
• Demonstrated leadership, problem solving, and conflict resolution skills.
• Possession of strong ability and scientific curiosity to develop and continuously maintain the highest scientific and medical expertise needed to be a respected thought-partner to external academic scientists and clinical experts.
• In addition to the Nuvalent core values of Patient Impact, Empowerment, and Collaboration, expectation is the ability to drive the work focused on growth, accountability, transparency and utmost ethical mindset.

Qualifications:

• Advanced degree preferred (MD, PhD, or PharmD).
• Prior experience in oncology and/or rare disease required.
• 15+ years’ experience in Medical Affairs, ideally working in a small and growing biotech.
• Proven track record of leading and building Medical Affairs functions and teams.
• Experience successfully integrating Medical Affairs within a corporate governance structure and internal cross-functional teams.
• Successful product launches within oncology and rare disease, both US and ex-US
• Direct interactions or demonstrated understanding of engaging with payer organizations, health technology assessors, and/or regulatory agencies.
• Ability to successfully build relationships and manage multiple consultants/vendors.
• In-depth understanding of and operating within a publicly traded corporate, regulatory, and FDA compliant environment.
• Up-to-date knowledge of external trends and experience implementing innovative solutions to improve the efficiency and demonstrate the value of Medical Affairs.
• Routine travel (up to 50%) will be required between various locations in U.S. and occasional international travels.