Senior Director, Medical Affairs

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About Formation Bio

*Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.*

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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.

Responsibilities

Medical & Scientific Strategy

• + 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.

External Scientific Engagement

• + 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.

Publications & RWE

• + 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.

Medical Affairs Build-Out

• + 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.

Launch & Cross-Functional Partnership

• + 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.

Patient & Advocacy Engagement

• + Develop strategy for engagement with patient advocacy groups and medical societies to inform development, education, and access.

About You

• 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.

Compensation:

The target salary range for this role is: $325,000 - $425,000

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.