Vice President, Clinical Operations

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: 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  Formation Bio is seeking a Vice President of Clinical Operations to build and lead the end-to-end clinical operations function, spanning site activation, trial execution, and data infrastructure. 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. This leader will partner tightly with the SVP of Therapeutic Development and asset-level clinical teams to deliver high-velocity, high-quality trial execution across a growing portfolio. Given Formation’s tech-forward model, candidates must bring not only deep operational expertise but also a sharp, defensible point of view on where AI and automation should replace traditional clinical operations workflows and the track record to back it up when it comes to applying AI and digital tools to compress timelines, elevate site performance, and generate richer, machine-ready trial data. Candidates who view AI as a nice-to-have rather than the operating model will not be the right fit. Responsibilities Site Start-Up and Patient Recruitment Lead global site identification, feasibility assessment, and start-up execution across Formation’s clinical portfolio, leveraging AI-powered site performance analytics fed by third-party enrollment intelligence, public trial registries, and real-world patient data to build the predictive infrastructure that prioritizes sites with the highest probability of on-time activation and patient accrual, and that compounds in value as Formation accumulates its own trial data over time. 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. Own Formation’s hybrid clinical execution model: Formation internalizes the strategic and analytical functions that drive competitive advantage, site selection intelligence, AI-powered enrollment forecasting, monitoring strategy, and data quality governance. 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.  Clinical Trial Management Own operational delivery across Formation’s active clinical programs with a mandate to outperform industry benchmarks. Success is measured by materially faster site activation timelines, enrollment rates that compress development cycles, and data quality that flows cleanly into Formation’s AI infrastructure without rework. “On time, on budget” is a floor. Apply AI-driven trial monitoring and risk-based monitoring (RBM) approaches to increase oversight efficiency and reduce on-site burden without compromising data integrity. 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. Formation internalizes monitoring strategy, data quality governance, ARK platform integration, and real-time trial analytics. 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. Technology that doesn’t integrate with Formation’s ARK data backbone doesn’t belong in the stack. Drive a culture of fast, high-quality execution, framing operational decisions in terms of risk, uncertainty, and expected value rather than precedent or convention. AI-Native Operations Integration 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. 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. This is not incremental modernization. Candidates who see this as “adding AI tools to existing workflows” are not the right fit. Drive adoption of Formation’s ARK platform as the operational and data b