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Formation Bio is a tech and AI-driven pharma company accelerating drug development through radically more efficient clinical trials. Founded in 2016 (originally TrialSpark), the company partners with pharma, biotech, and research organizations to develop candidate drugs past clinical proof of concept, backed by top-tier investors including a16z, Sequoia, Sanofi, and Thrive Capital.
The Trial Execution team is solving a critical bottleneck: clinical trials are slow and expensive because site activation takes months, data arrives fragmented from incompatible systems, and teams spend weeks reconciling spreadsheets instead of making decisions. This role is a senior technical seat on that team.
As Senior Software Engineer II, you'll be a senior individual contributor and technical owner of a meaningful slice of the Trial Execution platform. You'll drive multi-quarter initiatives from opportunity identification through shipping and operating differentiated software used in active trials. The work spans integrations with EDC and clinical systems, site selection and activation, clinical data flows, monitoring and signal detection, and timeline reconciliation across CROs and vendors.
A key constraint—and design opportunity—is the regulated environment. Systems touching patient safety or trial integrity are GxP-relevant, requiring computer system validation, 21 CFR Part 11 compliance, audit trails, and traceability. Rather than treating this as a wall, Formation Bio sees it as a design problem. You'll increasingly work on agentic systems—AI agents reading source data to surface discrepancies, signals, and tasks—designed to be auditable, provenance-tracked, and appropriately human-in-the-loop.
You'll partner directly with Clinical Operations, Data Management, Regulatory, QA, Data Engineering, and Infrastructure to develop systems, integrations, data flows, and controls required for production deployment. You'll bring familiarity with regulated delivery to identify GxP implications early and engage validation experts. Responsibilities include owning design and delivery of production software for live trials, translating validation requirements into traceable software within a validated SDLC, designing AI-native trial execution capabilities, building integrations across the clinical vendor landscape, owning trial-specific domain logic, and shifting work left to improve efficiency.
