Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

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. 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. Candidates must bring deep operational expertise and a sharp point of view on where AI and automation should replace traditional clinical operations workflows.

Responsibilities

Lead global site identification, feasibility assessment, and start-up execution across Formation’s clinical portfolio, leveraging AI-powered site performance analytics.
Design and oversee patient recruitment strategies that integrate digital outreach, decentralized trial elements, and real-world data signals.
Own Formation’s hybrid clinical execution model, defining what is built, owned, and outsourced, and holding vendors accountable to performance standards.
Own operational delivery across Formation’s active clinical programs with a mandate to outperform industry benchmarks.
Apply AI-driven trial monitoring and risk-based monitoring (RBM) approaches to increase oversight efficiency.
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.
Own Formation’s clinical technology stack as an internal strategic asset, making build-vs.-buy decisions across eClinical platforms and decentralized trial modalities.
Drive a culture of fast, high-quality execution, framing operational decisions in terms of risk, uncertainty, and expected value.
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.
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.
Oversee clinical data management operations, including EDC configuration and governance, data cleaning workflows, and data lock processes.
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.
Build operational analytics dashboards that provide real-time visibility into trial health metrics.
Build and develop a high-performing clinical operations team capable of operating in a high-autonomy, high-accountability environment.
Architect and oversee a highly leveraged external network of CROs, vendors, and technology partners.
Develop the operational infrastructure — SOPs, systems, and metrics — that enables Formation to scale clinical execution 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, Biostatistics & Data Science, Regulatory, and AI/Platform teams.

Requirements

10+ years of clinical operations leadership, including direct responsibility for global multi-site Phase 2 and Phase 3 trials.
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.
Hands-on experience with AI-driven trial monitoring, risk-based monitoring platforms, or adaptive trial management tools is required.
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.
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.
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.
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.

Skills

AI-driven trial monitoring
Risk-based monitoring (RBM)
Adaptive trial management
eClinical technologies
Data management platforms
EDC
CTMS
eTMF
ePRO/eCOA systems
Site start-up
Enrollment
Trial monitoring
Data management
GCP compliance
AI and technology fluency
Quantitative orientation
Data literacy
Risk-forward decision making
Process building
System building
Team scaling
Cross-disciplinary team building
Communication

Location

New York City metro area
Boston metro area
Research Triangle (NC)
San Francisco Bay Area

Work Type

Hybrid

Experience Level

10+ years of clinical operations leadership
Vice President

Salary/Compensations

$350,000 - $425,000

Benefits

Equity
Comprehensive benefits
Generous perks

About the Company

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.
Formation Bio has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.
The company partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond.
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.
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.

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.