Senior Director, Medical Affairs

Formation Bio•Boston, MA

1d•$325,000 - $425,000

About The Position

The Senior Director, Medical Affairs is a first-in-function leadership role responsible for building and leading Medical Affairs capabilities across Formation Bio’s growing portfolio. This role will establish the scientific foundation for programs spanning late-stage development to commercialization, with an initial focus on our lead asset, Sprifermin. This leader will serve as a strategic scientific partner to Clinical Development, Regulatory, Commercial, and Portfolio teams, ensuring that Medical Affairs strategy, scientific exchange, and evidence generation are embedded early and executed with rigor, compliance, and credibility. The Senior Director will design scalable medical affairs infrastructure, lead external scientific engagement, and build a high-impact Medical Affairs team—including the future build-out of a field-based Medical Science Liaison (MSL) team.

Requirements

10+ years of experience in Medical Affairs and/or Clinical Development within biopharma or biotech, with increasing leadership responsibility.
Advanced scientific or clinical degree (PhD, PharmD, MD, or equivalent) strongly preferred.
Demonstrated experience developing and executing medical strategy across late development, pre-launch, and commercialization.
Experience building or scaling medical affairs capabilities, including MSL teams.
Deep understanding of medical compliance, scientific exchange regulations, and industry best practices.
Strong cross-functional partner with experience working closely with Clinical, Regulatory, Commercial, and Portfolio teams.
Track record of credible external engagement with KOLs, investigators, and scientific stakeholders.
Exceptional communication skills with the ability to synthesize complex data into clear strategic insights.
Hands-on leadership style with comfort operating in a fast-growing, resource-lean environment.
Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate.

Responsibilities

Lead medical affairs and scientific strategy across assigned programs, from late development through pre-launch and commercialization readiness.
Embed medical perspective early in development planning, including endpoint selection, evidence generation, and lifecycle strategy.
Provide medical and scientific input into asset diligence, in-licensing evaluations, and portfolio strategy.
Develop and execute a comprehensive KOL engagement strategy, building durable relationships with external experts, investigators, and scientific leaders.
Lead scientific exchange activities, including advisory boards, congress strategy, and external data communication.
Serve as a credible scientific leader representing Formation Bio programs externally with rigor and integrity.
Own publication planning and execution, ensuring timely, compliant dissemination of clinical and real-world data.
Support Phase IV, real-world evidence (RWE), and observational studies in partnership with Clinical and internal stakeholders.
Translate evidence into clear medical narratives that inform development, access, and launch readiness.
Establish scalable medical affairs processes, governance, and operating models appropriate for a multi-asset organization.
Build and lead the Medical Affairs function over time, including the planned launch and management of a field-based Medical Science Liaison (MSL) team.
Balance internal capabilities with external vendors and partners to maximize efficiency and impact.
Support launch readiness through medical education strategy, scientific positioning, and internal training.
Provide medical affairs input into value narratives, HEOR strategy, and reimbursement dossiers in collaboration with cross-functional teams.
Develop strategy for engagement with patient advocacy groups and medical societies to inform development, education, and access.