Vice President, Clinical Operations

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 deep operational expertise and a defensible perspective on where AI and automation should replace traditional clinical operations workflows, with a track record of applying AI and digital tools to compress timelines, elevate site performance, and generate richer, machine-ready trial data. 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 to prioritize sites with high probability of on-time activation and patient accrual. 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. Own Formation’s hybrid clinical execution model, defining which functions are built internally, outsourced, or governed through vendor accountability. Clinical Trial Management Own operational delivery across active clinical programs, delivering faster site activation timelines, enrollment rates that compress development cycles, and high data quality flowing into Formation’s AI infrastructure. Serve as the primary operational interface with senior leadership, translating AI-optimized protocol designs into detailed operational plans with explicit resources, timelines, and risk assumptions. Own Formation’s clinical technology stack as an internal strategic asset, making build‑vs‑buy decisions across eClinical platforms and ensuring integration with Formation’s ARK data backbone. Drive a culture of fast, high‑quality execution, framing decisions in terms of risk, uncertainty, and expected value. AI‑Native Operations Integration Partner with AI and data science teams to embed machine learning and predictive analytics into site selection, enrollment forecasting, deviation detection, and real‑time trial oversight. Define and own the operational model where Formation internalizes the intelligence layer and deploys CROs as disciplined execution partners. Drive adoption of Formation’s ARK platform as the operational and data backbone of every trial. Evaluate and deploy emerging digital tools—including eClinical systems, decentralized trial technologies, and AI‑assisted monitoring—to compress timelines and improve data quality. Data Management and Analytics Oversee clinical data management operations, ensuring trial data flows cleanly into Formation’s ARK platform for downstream AI analysis. Partner with data science and biostatistics to define operational data standards that maximize utility for machine learning, real‑time safety surveillance, and adaptive trial execution. Build operational analytics dashboards for real‑time visibility into trial health metrics such as enrollment rates, protocol deviation trends, and data query resolution rates. Organization Building and External Network Build and develop a high‑performing clinical operations team capable of operating in a high‑autonomy, high‑accountability environment. Architect and oversee a leveraged external network of CROs, vendors, and technology partners; build vendor governance structures that deliver performance accountability. Develop the operational infrastructure—SOPs, systems, metrics—to enable scale across therapeutic areas and developmental stages with capital efficiency. Cross‑Functional Leadership Partner closely and operate as a fully integrated member of Formation’s clinical and R&D leadership, collaborating tightly with Therapeutic Development, Biostatistics & Data Science, Regulatory, and AI/Platform teams. About You Experience & Background 10+ years of clinical operations leadership, including direct responsibility for global multi‑site Phase 2 and Phase 3 trials, with demonstrated success accelerating enrollment timelines. 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 and concrete results. Experience operating in a hybrid model with a track record of building vendor governance structures that deliver performance accountability. Experience across multiple therapeutic areas preferred; breadth valued over narrow specialization. Core Capabilities Operational mastery across site start‑up, enrollment, trial monitoring, data management, and GCP compliance. AI and technology fluency with a clear view on internalization versus outsourcing and evidence of execution. Quantitative orientation and data literacy, partnering effectively with data scientists and biostatisticians. Risk‑forward decision maker, willing to challenge convention and frame decisions in expected value and probability. Builder and operator with experience standing up processes, systems, and teams and scaling capabilities with lean, high‑accountability teams. Leadership Traits Proven builder of high‑performing cross‑disciplinary teams in fast‑paced environments. High ownership, low ego, and strong collaboration across scientific, technical, and business stakeholders. Thrives in dynamic, high‑velocity environments with evolving priorities. Clear, concise communicator who translates operational complexity into strategic insight for senior leadership. Comfortable challenging assumptions and driving clarity under uncertainty. Total Compensation Range $350,000 - $425,000 Compensation Individual compensation is determined by role scope, geographic location, and skills & experience. Offers will reflect appropriate range placement. In addition to base salary, equity, comprehensive benefits, and generous perks are included. Where We Hire Formation Bio prioritizes hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring three days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered; applicants must reside in or be willing to relocate to one of these locations. 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, 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. #J-18808-Ljbffr Initial Therapeutics, Inc.