Formation Bio
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Senior Director, Clinical Pharmacology
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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, John Doerr, Spark Capital, SV Angel Growth, and others.
You can read more at the following links:
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
Formation Bio is seeking an experienced and innovative Senior Director of Clinical Pharmacology to join our Development team. In this role, you will lead our clinical pharmacology efforts, supporting late-stage drug development and contributing to business development activities. You will play a crucial role in advancing our mission to bring new treatments to patients faster and more efficiently through our innovative, tech-enabled drug development platform.
The role reports to the VP of Translational Medicine and you will be a key member of the Formation Bio Development team.
Responsibilities
- Develop clinical pharmacology strategy consistent with the target product profile, program goals and regulatory strategy
- In collaboration with the Clinical Development team, define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label
- Lead clinical pharmacology activities in supporting late-stage drug development programs across multiple therapeutic areas
- Design and oversee the execution of clinical pharmacology studies to support clinical development and regulatory submissions
- Determine scope, design, plan and analyze Phase 1-IV PK and PD studies, including development of appropriate population PK models.
- Contribute clinical pharmacology expertise to due diligence efforts for potential in-licensing opportunities
- Serve as the primary Clin Pharm lead and effectively participate in cross-functional teams to ensure integration of modern clinical pharmacology principles into project plan and study design
- integrated development strategies
- Provide scientific leadership in interactions with regulatory agencies and external partners
- Develop and implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology studies
- Manage resources, timelines, and budget for clinical pharmacology activities
- Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation
- Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings
- Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents
About You
- PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role in conduct and/or oversight of clinical pharmacology
- Proven track record in leading clinical pharmacology efforts in late-stage drug development
- Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
- Competent in the use of PK and PK/PD modeling software tools
- Experience in due diligence activities for in-licensing opportunities
- Excellent communication and leadership skills
- Ability to work effectively in a fast-paced, cross-functional environment
- Innovative mindset and enthusiasm for leveraging technology in drug development
Total Compensation Range: $311,000 - $388,500
Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!
Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.
Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
Ready to apply?
Apply to Formation Bio
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, John Doerr, Spark Capital, SV Angel Growth, and others.
You can read more at the following links:
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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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.
Total Compensation Range: $325,000 - $425,000
Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!
Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.
Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
Ready to apply?
Apply to Formation Bio