Vice President, Clinical Operations

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. The company builds technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials, working with pharma companies, research organizations, and biotechs. Formation Bio was founded in 2016 as TrialSpark Inc. and is backed by investors including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital and SV Angel Growth. About The Position Formation Bio is seeking a Vice President of Clinical Operations to build and lead the end‑to‑end clinical operations function, including site activation, trial execution, and data infrastructure. The VP of Clinical Operations is the operational backbone of our clinical engine, converting AI‑optimized protocols into rigorously executed trials. Responsibilities Site Start‑Up and Patient Recruitment Lead global site identification, feasibility assessment and start‑up execution for our clinical portfolio, leveraging AI‑powered site performance analytics and real‑world patient data to build predictive infrastructure that prioritises sites with the highest 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 populations at scale. Own Formation’s hybrid clinical execution model: define what we build, what we own, and what we outsource, and hold vendors accountable to our performance standards. Clinical Trial Management Own operational delivery across active clinical programs, measuring faster site activation timelines, compressed enrollment rates and clean data flow into our AI infrastructure. Apply AI‑driven trial monitoring and risk‑based monitoring to increase oversight efficiency. Serve as primary operational interface with SVP/VP Therapeutic Development and asset‑level clinical teams, translating AI‑optimized protocol designs into detailed operational plans. Own Formation’s clinical technology stack, making explicit build‑vs‑buy decisions for eClinical platforms, ePRO/eCOA tools and decentralized modalities, ensuring integration with our 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, protocol deviation detection and real‑time oversight. Define and own the model of “AI‑native clinical operations” where the intelligence layer is internalised and CROs act only as execution partners. Drive adoption of the ARK platform as the operational and data backbone of every trial. Evaluate and deploy emerging digital tools including eClinical systems, decentralized technologies and AI‑assisted monitoring to compress timelines and improve data quality. Data Management and Analytics Oversee clinical data management operations, including EDC configuration, governance, data cleaning workflows and lock processes, ensuring clean data flow into the ARK platform. Partner with data science and biostatistics to define operational data standards that maximise utility for machine learning, real‑time safety surveillance and adaptive trial execution. Build operational analytics dashboards that provide 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 in a high‑autonomy, high‑accountability environment. Architect and oversee a highly leveraged external network of CROs, vendors and technology partners, building vendor governance structures that deliver performance accountability without bureaucratic overhead. Develop SOPs, systems and metrics that enable scalability of clinical execution across therapeutic areas and development stages with capital efficiency. Cross‑Functional Leadership Partner closely and operate as a fully integrated member of the clinical and R&D leadership team. Collaborate with Therapeutic Development, Biostatistics & Data Science, Regulatory, AI/Platform teams to embed technology capabilities into day‑to‑day execution. About You Experience & Background 10+ years of clinical operations leadership, with direct responsibility for global multi‑site Phase 2 and Phase 3 trials and 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. Hands‑on experience with AI‑driven trial monitoring, risk‑based monitoring platforms or adaptive trial management tools; must be able to speak concretely to operational results. Experience operating in a hybrid model and building vendor governance structures that deliver performance accountability without bureaucratic overhead. 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: concrete, opinionated view on which functions should be internalised and AI‑powered, with a track record of acting on that view. Quantitative orientation and data literacy; view clinical operations as a data‑generating asset, not a logistics function. Risk‑forward decision maker, willing to challenge convention, make bold well‑reasoned calls, and frame decisions in terms of expected value and probability of success. Builder and operator with experience translating strategy into execution with lean, high‑accountability teams. Leadership Traits Proven builder of high‑performing, cross‑disciplinary teams in fast‑paced environments. High ownership, low ego, strong collaborator across scientific, technical, and business stakeholders. Thrives in dynamic, high‑velocity environments with evolving priorities. Clear, concise communicator capable of translating 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 factors including role scope, geographic location and skills & experience. Base salary, equity, comprehensive benefits and generous perks are included. If the posted range doesn’t match your expectations, you are still encouraged to apply. Where We Hire Formation Bio prioritises 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. 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. #J-18808-Ljbffr Formation Bio