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Formation Bio
Boston, MA; New York, NY
Source: Formation Bio careers · View original posting
From Formation Bio's posting. “We” and “our” refer to the employer.
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.
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.
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.
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
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 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.
We've seen a rise in recruiting impersonation scams across the industry, where fake profiles pose as recruiters aiming to trick candidates into sharing personal and financial information through illegitimate interviews and job offers. All legitimate recruiting communications from Formation Bio will come from a @formation.bio email address. If you receive outreach from someone claiming to work at Formation Bio through any other domain or channel, please disregard it and do not share any personal information.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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