Senior Software Engineer II, Trial Engine
Formationbio · New York, NY; Boston, MA
About this role
**Senior Software Engineer II, Trial Engine** **About Formation Bio** Formation Bio is a tech and AI-driven pharma company focused on radically more efficient drug development. Founded in 2016, the company builds technology platforms to accelerate drug development and clinical trials, partnering with pharma companies, research organizations, and biotechs. **About the Position** The Trial Execution team is building systems to fix the slow and expensive parts of clinical trials. This senior role focuses on regulated software delivery—systems touching patient safety and trial integrity require GxP compliance, computer system validation, and audit trails. You'll design solutions that work within these constraints rather than around them. You'll build systems for active trials: EDC integrations, site activation, clinical data flows, monitoring, and signal detection. Increasingly, this includes agentic AI—agents reading source data to surface discrepancies and tasks—designed to be auditable, provenance-tracked, and appropriately human-in-the-loop. **Key Responsibilities** • Design and own production software for live clinical trials from startup through close-out • Partner with Clinical Operations, Data Management, Regulatory, QA, and Infrastructure teams • Build within a validated SDLC; work with QA and CSV experts on compliant delivery • Design AI-native trial execution capabilities with proper audit trails and human review • Build integrations across clinical systems (EDC, CTMS, eTMF, CRO feeds, safety systems) • Own trial-specific domain logic and clinical data software • Mentor engineers and set technical direction **About You** • 7+ years building production software, including hands-on experience shipping software for clinical trials • Familiarity with regulated environments: GxP/GCP, computer system validation, audit trails, change control • See regulation as a design constraint, not a barrier • Strong builder: clean code, distributed systems, cloud fundamentals (AWS/GCP/Azure) • Daily experience with AI tools (LLMs, agentic workflows, retrieval pipelines) • Track record of technical ownership at senior scope • Excellent communicator with non-engineers • Comfortable with ambiguity **Compensation & Location** $213,500 - $267,000 + equity and benefits Priority hiring: NYC and Boston metro areas (hybrid, 3 days/week in office). Research Triangle (NC) and San Francisco Bay Area also considered.
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