Formation Bio
Vice President, Clinical Operations
Boston, MA; New York, NY · Exec
Sponsorship not specifiedDetected 22 days ago
GCPMachine LearningSparkData ScienceForecastingLogisticsResearchLeadershipBiostatistics
About the role
- About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
- 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.
- The VP of Clinical Operations is the operational backbone of Formation's clinical engine - the leader who converts AI-optimized protocols into rigorously executed trials.
Responsibilities
- Design and oversee patient recruitment strategies that integrate digital outreach, decentralized trial elements, and real-world data signals to identify and engage eligible patient populations at scale, consistent with Formation's commitment to faster, smarter enrollment.
- This leader will define precisely what we build, what we own, and what we outsource, and will hold vendors accountable to Formation's performance standards rather than the other way around.
- Own operational delivery across Formation's active clinical programs with a mandate to outperform industry benchmarks.
- Serve as the primary operational interface with the SVP/VP, Therapeutic Development and asset-level clinical teams, translating AI-optimized protocol designs into detailed operational plans with explicit resource, timeline, and risk assumptions.
- Own Formation's clinical technology stack as an internal strategic asset.
- This leader will make explicit build-vs.-buy decisions across eClinical platforms, ePRO/eCOA tools, and decentralized trial modalities, and will be held accountable for those choices.
- Drive a culture of fast, high-quality execution, framing operational decisions in terms of risk, uncertainty, and expected value rather than precedent or convention.
- Define and own what "AI-native clinical operations" means in practice at Formation, a model in which Formation internalizes the intelligence layer (site selection, enrollment prediction, deviation detection, data governance) and deploys CROs as disciplined execution partners rather than decision-makers.
- Drive adoption of Formation's ARK platform as the operational and data backbone of every trial, ensuring that operational decisions are informed by and feed back into Formation's broader AI development engine.
- Organization Building and External Network
Nice to have
- Deep fluency with modern eClinical technologies and data management platforms
- hands-on experience integrating EDC, CTMS, eTMF, and ePRO/eCOA systems into a unified operational infrastructure.
- Hands-on experience with AI-driven trial monitoring, risk-based monitoring platforms, or adaptive trial management tools is required.
- Candidates must be able to speak concretely to where they have applied these approaches and what the operational results were.
- Experience across multiple therapeutic areas preferred
- breadth valued over narrow specialization.
Benefits
- Our Vision for AI in Pharma
- Partner with Formation's AI and data science teams to embed machine learning and predictive analytics into site selection, enrollment forecasting, protocol deviation detection, and real-time trial oversight.
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