Senior Software Engineer II, Trial Engine
Formation Bio2 months ago
Responsibilities
- Own the design, delivery, and operation of production software used in live clinical trials from site startup through close-out.
- Coordinate clinical, regulatory, data, infrastructure, QA, and validation dependencies to deliver software into active trials.
- Build within a validated software development lifecycle and translate validation requirements into traceable, testable software.
- Design and ship AI-native agents and pipelines that analyze clinical and operational data with provenance, audit trails, and human review.
- Build integrations across EDC, CTMS, eTMF, CRO, laboratory, and safety-system data sources.
- Own trial-specific domain logic and partner with Data Engineering on ingestion, orchestration, warehouse, quality, and governance capabilities.
- Identify opportunities to shift trial activities earlier or run them in parallel through improved tooling.
- Recognize GxP implications and engage QA and validation partners early in engineering decisions.
- Set technical direction, review designs, mentor engineers, and improve organizational guardrails and automation.
Requirements
- 7+ years of experience building production software, including hands-on experience shipping software for use in a clinical trial.
- Familiarity with clinical systems, clinical data flows, and the operational realities of active trial environments.
- Experience with regulated or controlled software delivery, including GxP/GCP, computer system validation, requirements traceability, audit trails, electronic signatures, and change control.
- Ability to translate regulatory requirements into compliant, maintainable, and well-engineered software.
- Strong software-building skills with clean code, distributed-systems fundamentals, and cloud fundamentals using AWS, GCP, or Azure.
- Daily experience with AI tools, LLMs, agentic workflows, and retrieval pipelines, with interest in responsible use in regulated clinical work.
- Track record of technical ownership across multi-quarter efforts, cross-functional dependencies, and designs used by other engineers.
- Ability to communicate effectively with clinical operations, QA, and other non-engineering stakeholders.
- Comfort working with ambiguity and changing trial portfolios and roadmaps.
Benefits
- Equity, comprehensive benefits, and generous perks are offered in addition to compensation.
- Hybrid work model requiring 3 days per week in the office.
- Hiring is focused primarily on the New York City and Boston metro areas, with consideration for candidates in the Research Triangle and San Francisco Bay Area; applicants must reside in or be willing to relocate to these locations.
Tech Stack
Categories
About Formation Bio
Formation Bio builds AI-driven technology platforms and runs a pharmaceutical development business that designs and executes clinical trials for in-licensed or acquired drugs. It partners with pharma, biotechs, and research groups to take clinical-stage assets through proof of concept and beyond, aiming to reduce trial time and improve data quality. The privately held company is headquartered in New York and originated as TrialSpark before rebranding to Formation Bio.