Associate Director/Director of Data Governance, Formation Bio
$161.5-202k
3+ days a week in office
Powering hyper-efficient, tech-driven drug development
Be an early applicant
Powering hyper-efficient, tech-driven drug development
101-200 employees
Be an early applicant
$161.5-202k
3+ days a week in office
101-200 employees
Company mission
To bring new treatments to patients faster and more efficiently.
Role
Who you are
- 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
What the job involves
- 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
- 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
Our take
Clinical drug trials are lengthy and expensive, delaying the supply of vital new drugs to patients and costing lives. For Formation Bio, this is an efficiency issue - one which it hopes to solve with its end-to-end automation solution.
According to the company, its approach has teams running medical trials twice as fast and at half the cost. This success has pushed Formation to expand beyond supporting trials into developing assets itself. In 2025, it reached a major milestone by licensing its first drug in a deal worth up to hundreds of millions. Alongside this, the company has also added an early immunology program to its pipeline, signalling a broader push into in-house development.
Now a Unicorn, with partners including Pfizer, Sanofi, Novartis and 23andMe, Formation Bio is steadily embedding itself within the Big Pharma ecosystem. How far it can go remains an open question, but the prospect of cheaper drugs and faster innovation is becoming harder for the industry to ignore.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
30% employee growth in 12 months
Company
Funding (last 2 of 3 rounds)
Jun 2024
$372m
SERIES D
Sep 2021
$156m
SERIES C
Total funding: $530.3m
Company benefits
- Flexible Time Off: We have a flexible PTO policy and we encourage our team members to take the time that they need to recharge
- Parental Leave: All parents receive 12 weeks of fully paid bonding leave to welcome a newborn, adopted, or fostered child, and birthing parents are eligible for an additional 6-8 weeks of paid leave
- Comprehensive Benefits: All full time employees have access to health, vision, and dental insurance. Additionally, we provide pre-tax commuter benefits, access to a 401k plan, short and long-term disability and life insurance.
- Education & Career Development Resources: Formation Bio offers a plethora of professional development resources to employees, including a yearly L&D stipend, internal mobility opportunities, in depth trainings, leadership coaching, and more.
- Community: Our teams collaborate closely to achieve our mission, supporting each other across functions and priorities. We build connection through team-building events, quarterly company gatherings, a biennial company-wide retreat, and various Employee Resource Groups.
Company values
- Think in first principles: We rigorously interrogate all possible paths to understand how we can do things differently and faster. We challenge assumptions, ask why, and solve problems from the ground up
- Be a scientist: We are curious and we continuously learn. We steelman, not strawman in debates. We listen, rapidly iterate, and make the best decisions with the evidence we have
- Deliver care: We lead with empathy. We value different perspectives, collaborate across teams, and support one another. We give and receive direct, actionable and timely feedback to hold ourselves and others to a high bar
- Champion the mission: We keep the mission as our north star and deliver impact for patients. We hold ourselves accountable for our wins and failures and keep moving forward
Company HQ
Midtown South, New York, NY
Articles
Leadership
Benjamine Liu
(Co-Founder & CEO)Worked as a computational biologist at various Neurology departments, following a D.Phil in computational Biology and Psychiatry at Oxford. They are also an Advisor at Harvard Business School.
Linhao Zhang
(Co-Founder)Linhao is also the Founder of Foundation 649. Previously, they were a Product Engineer at Oscar Insurance, a Software Engineer at Salesforce, and co-founder of Day 7 Photography.
Dan Neil
(CTO)Prior to joining Formation Bio in 2025, Dan was the Chief Data Officer at Tessera Therapeutics. Before that, they spent nearly 7 years at BenevolentAI in various roles, including SVP of AI & NY Site Lead and CTO.
Dale Klasko
(Senior Vice President, People)Dale built her career as a campus recruiting leader and strategic people business partner at growth-stage companies in the adtech & finservices industries.
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