Building the pharma company of the future. Backed by Sequoia, a16z and Felicis.
About the role
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 .
What they're looking for
- 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 serving as a Process Owner or System/Business Owner, including SOP governance, KPI monitoring, and change control management
More about this role
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.
- Our Vision for AI in Pharma
- Our Current Drug Portfolio
- Our Technology & Platform
At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the...
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