Vice President, Clinical Operations

Formation Bio•Boston, NY

1d•Hybrid

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.

Requirements

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 in resource-constrained or virtual operating environments.
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 operating in a hybrid model and the intellectual honesty to know the difference between what must be internalized and what can be leveraged externally without sacrificing quality or speed; track record of building vendor governance structures that deliver performance accountability without bureaucratic overhead.
Experience across multiple therapeutic areas preferred; breadth valued over narrow specialization.
Operational mastery: deep expertise across site start-up, enrollment, trial monitoring, data management, and GCP compliance
AI and technology fluency: a concrete, opinionated view on which clinical operations functions should be internalized and AI-powered versus outsourced, and a track record of acting on that view. Enthusiasm is not enough; Formation needs someone who has already done this and can do it again faster
Quantitative orientation and data literacy: comfortable partnering with data scientists and biostatisticians; views 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: experience standing up processes, systems, and teams and then scaling clinical operations capabilities; understands how to translate strategy into execution with lean, high-accountability teams
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

Nice To Haves

Experience across multiple therapeutic areas preferred; breadth valued over narrow specialization.

Responsibilities

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.
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.
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 backbone of every trial, ensuring that operational decisions are informed by and feed back into Formation’s broader AI development engine.
Evaluate and deploy emerging digital tools — including eClinical systems, decentralized trial technologies, and AI-assisted monitoring — to compress timelines and improve data quality across the portfolio.
Oversee clinical data management operations, including EDC configuration and governance, data cleaning workflows, and data lock processes, ensuring that trial data flows cleanly and efficiently into Formation’s ARK platform for downstream AI analysis.
Partner with data science and biostatistics to define operational data standards and collection requirements that maximize the utility of trial data for machine learning applications, real-time safety surveillance, and adaptive trial execution.
Build operational analytics dashboards that provide real-time visibility into trial health metrics — including enrollment rates, protocol deviation trends, and data query resolution rates — enabling proactive rather than reactive trial management.
Build and develop a high-performing clinical operations team capable of operating in a high-autonomy, high-accountability environment consistent with Formation’s culture and pace.
Architect and oversee a highly leveraged external network of CROs, vendors, and technology partners; build vendor governance structures that deliver performance accountability without bureaucratic overhead.
Develop the operational infrastructure — SOPs, systems, and metrics — that enables Formation to scale clinical execution across therapeutic areas and development stages with capital efficiency.
Partner closely and operate as a fully integrated member of Formation’s clinical and R&D leadership, collaborating tightly with: Therapeutic Development — to translate clinical strategy into executable operational plans Biostatistics & Data Science — to define data requirements and integrate adaptive and AI-driven trial designs Regulatory — to ensure operational plans align with innovative regulatory pathways AI/Platform teams — to embed Formation’s technology capabilities into day-to-day operational execution