---
title: 'Associate Director/Director, Data Governance at Formation Bio'
canonical: 'https://feeny.ai/job/associate-director-director-data-governance-formation-bio-boston-xx5v9a3egg60'
type: 'job'
last_seen: '2026-09-05'
---

# Associate Director/Director, Data Governance at Formation Bio

- **Company:** Formation Bio
- **Location:** Boston, MA / New York, NY
- **Posted:** 2026-08-24
- **Last confirmed live:** 2026-09-05
- **Apply:** https://job-boards.greenhouse.io/formationbio/jobs/8120161

## Job description

## 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](https://www.formation.bio/blog/our-vision-for-ai-in-pharma)
- [Our Current Drug Portfolio](https://www.formation.bio/licensing-and-pipeline)
- [Our Technology & Platform](https://www.formation.bio/technology)

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

The Data Governance Associate Director/Director is a critical member of the Quality Governance team, with a primary focus on data governance and AI oversight across Formation Bio's R&D organization. This role serves as Process Owner for R&D Data and Records Integrity and as Business Owner for key quality technology systems (Veeva Quality Docs, DocuSign Part 11), and owns the organization's inventory of R&D data and AI applications, along with their associated risk assessments. Reporting directly to the Head of Quality with no intermediate management layer, this role builds and maintains the data governance framework that governs how R&D data is stewarded, sourced, and controlled, and performs and approves AI risk assessments and oversight activities for AI tools used across R&D, ensuring appropriate guardrails, human review, and accountability. This role also drives cross-functional R&D data migration and digitization initiatives and ensures R&D data, AI tools, and computerized systems remain in a continued state of control and compliance with Formation Bio standards and applicable regulations. At the Director level, this role also sets R&D data governance and AI oversight strategy and represents Quality Governance during regulatory inspections.

## Responsibilities

- Serve as Process Owner for R&D Data and Records Integrity and Business Owner for Veeva Quality Docs and DocuSign Part 11, ensuring these processes and systems remain accurate, current, and effective
- Own and maintain the R&D data governance framework, including the inventory of R&D data (categories, stewards/owners, source of truth, retention requirements, and access controls) and associated risk assessments
- Apply risk assessments and control strategies to initial context of use, changes in context of use, and functionality changes for computerized systems and AI tools
- Maintain the inventory of AI applications in use across R&D and provide ongoing AI oversight, including periodic review of deployed models to assure a continued state of control, compliance, and appropriate human accountability
- Serve as a key R&D partner on data governance matters, advising R&D teams on data stewardship, data quality, and responsible AI adoption in day-to-day R&D workflows
- Own and drive strategy for large cross-functional data migration and digitization projects, including asset onboarding/acquisition and system changes
- Establish guardrails, in partnership with Operational Excellence, for the use of AI in QMS process execution (e.g., AI-assisted investigation drafting, CAPA analysis, audit preparation)
- Contribute to and support the QA master audit schedule and vendor qualification program, including evaluating vendors' use of AI or other automated systems in GxP-impacting work
- Oversee, review, and provide final approval for non-program-specific Quality Events, Investigations, and CAPAs
- Represent Quality Governance in regulatory inspections and third-party audits, and support inspection readiness activities
- Partner cross-functionally with R&D, IT, and Operational Excellence to embed Quality by Design principles into data, AI, and systems governance

## About You

- 7+ years (Associate Director) or 10+ years (Director) of progressive GxP quality assurance, data integrity, or computerized systems compliance experience in pharmaceutical, biotech, or related regulated industry
- Bachelor's degree in a scientific, engineering, information systems, or related discipline
- Strong working knowledge of data integrity principles (e.g., ALCOA+) and applicable GMP, GCP, and/or GLP regulations as they pertain to data, records, and computerized systems
- Demonstrated experience with computer system assurance/validation, including risk-based approaches to initial context of use, change in context of use, and functionality changes
- Working knowledge of AI/ML risk concepts—including model validation, bias, explainability, and drift monitoring—sufficient to design and approve AI risk assessments and mitigation strategies
- Demonstrated experience building or maintaining data governance artifacts within an R&D setting—such as data inventories, data stewardship models, retention schedules, and access control frameworks—and overseeing AI applications used in R&D processes
- Demonstrated experience serving as a Process Owner or System/Business Owner, including SOP governance, KPI monitoring, and change control management
- Experience leading or contributing substantively to cross-functional data migration, asset onboarding, or system change projects
- Strong cross-functional communication and collaboration skills, with experience representing Quality Assurance in working groups, inspections, or regulatory interactions
- Demonstrated ability to operate with a high degree of independence, exercising sound judgment in a role reporting directly to the Head of Quality with no intermediate management layer

Total Compensation Range: $161,500 - $202,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!

Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 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.

## About Formation Bio

## Company Overview
- **One-liner**: Formation Bio is an AI-native, tech-driven pharmaceutical company that acquires and develops clinical-stage drug candidates faster and more efficiently using its proprietary technology platform.
- **Entity Type**: Private (Series D)
- **Headquarters**: New York, New York, USA
- **Founded**: Year not publicly specified; founded by Ben Liu and Linhao Zhang
- **Founders**: Ben Liu (CEO & Co-Founder) and Linhao Zhang (Co-Founder)

## Core Business
- **Primary industry**: Pharmaceuticals / Drug Development / AI in Biotech
- **Target customers**: B2B; partners include pharmaceutical companies, universities, and biotech firms that have clinical-stage assets; end customers are patients awaiting new treatments.
- **Mission or purpose statement**: "To bring new treatments to patients faster and more efficiently."

## Products & Services
- **AI-Native Drug Development Platform**: A proprietary, tech-driven platform that integrates patient intelligence, data surveillance, and a universal data layer to power hyper-efficient clinical development across the drug lifecycle.
- **Drug Asset Acquisition & Development**: Formation Bio acquires promising clinical-stage drug candidates from pharma, universities, and biotech, then develops them in-house using flexible financing pathways and bespoke exit strategies.
- **Clinical Operations**: In-house management of trials including patient recruitment, site management, and study monitoring.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (private company)
- **Total Funding**: Not publicly disclosed in search results; investors include Sequoia Capital, a16z (Andreessen Horowitz), Thrive Capital, Section 32, Sam Altman, Michael Moritz, John Doerr, and others.
- **Notable Investors/Partners**: Sequoia Capital, a16z, Thrive Capital, Section 32, Sam Altman, Michael Moritz, John Doerr; advisors include former Pfizer CSO Mikael Dolsten, former Allergan R&D head Lawrence Olanoff, and Microsoft EVP of CoreAI Jay Parikh.
- **Growth Signals**: The team and advisors have collectively worked on 45+ approved drugs; the company is actively hiring across multiple functions (engineering, data science, clinical operations, business development) in four key hubs; has attracted top-tier tech and pharma talent.

## Competitive Advantages
- **AI-Native Model**: Unlike traditional pharma, Formation Bio is built from first principles with AI and data-driven iteration at its core, creating feedback loops that accelerate decision-making.
- **In-House Execution**: Runs trials in-house (patient recruitment, site management, monitoring) rather than outsourcing, enabling tighter control and faster cycles.
- **Cross-Industry Talent**: Bridges the best of tech and pharma, combining software engineering, data science, and AI with deep drug development expertise.
- **Flexible Deal Structures**: Offers varied financing and exit pathways for drug programs, making it a preferred partner for asset holders.

## Strategic Focus
- **Radical Efficiency**: Ruthless process improvement across the drug development lifecycle without sacrificing quality or safety.
- **Platform Scaling**: Building a scalable, tech-driven pharma company that can handle multiple drug programs simultaneously.
- **Therapeutic Breadth**: Focusing on critical unmet patient needs across a variety of therapeutic areas.

## Why Work Here
- **Mission-Driven**: "The world’s hardest problems deserve the world’s best people" — employees work on transforming how medicines are created, with tangible patient impact.
- **Hybrid Culture**: Teams are hybrid based in four hubs: New York City, Boston, San Francisco Bay Area, and North Carolina’s Research Triangle.
- **Comprehensive Benefits**: Health, vision, dental insurance; 401k; pre-tax commuter benefits; short and long-term disability; life insurance.
- **Parental Leave**: 16 weeks paid for birthing parents, 12 weeks for non-birthing parents.
- **Flexible PTO**: Trust-based time off policy.
- **Professional Development**: Fireside chats with industry experts, conference passes, certification courses, internal mobility, manager training, leadership coaching.
- **Community**: Quarterly company gatherings, bi-annual company-wide retreat, Employee Resource Groups.
- **Engineering Culture**: AI-native, data-driven, first-principles thinking — a place for people who "chase excellence" and want to solve hard problems.

## Sources
1. [formation.bio](https://www.formation.bio/)
2. [formation.bio/about-us](https://www.formation.bio/about-us)
3. [formation.bio/careers](https://www.formation.bio/careers)
4. [formation.bio/our-model](https://www.formation.bio/our-model)
5. [Greenhouse job board](http://job-boards.greenhouse.io/formationbio)

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