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About the Role
Formation Bio is seeking a Senior Software Engineer II to join the Trial Execution team. This role involves building systems that run active clinical trials, including integrations with clinical systems, site selection, data flows, and monitoring. The position focuses on designing auditable, provenance-tracked, and human-in-the-loop systems, particularly for AI-driven capabilities within a regulated GxP environment. The engineer will be a technical owner of a significant part of the Trial Execution platform, driving projects from conception through operation.
Responsibilities
- Drive and own the design, delivery, and operation of differentiated production software used in live clinical trials, from site startup and activation through data collection, monitoring, and close-out.
- Bring together clinical, regulatory, data, and infrastructure partners to resolve cross-functional dependencies and take software from technical design through validated use in active trials.
- Build within a validated SDLC: partner with QA and CSV experts to translate validation requirements into traceable, testable software, and improve the engineering workflows that make compliant delivery efficient and predictable.
- Design and ship AI-native trial execution capabilities — agents and pipelines that read clinical and operational source data to surface signals, discrepancies, and tasks — with the provenance, audit trails, and human review that a regulated context requires.
- Build integrations across the clinical systems and vendor landscape (EDC, CTMS, eTMF, CRO and lab data feeds, safety systems), and turn fragmented inputs into a coherent, queryable picture of a trial.
- Own the trial-specific domain logic and software built on clinical data, partnering with Data Engineering on shared ingestion, orchestration, warehouse, quality, and governance capabilities that clinical teams can trust and that stand up to inspection.
- Shift work left. Find the trial activities that traditionally happen sequentially and build the tooling that lets them start earlier or run in parallel.
- Develop strong working fluency in the team's regulated context. Recognize when GxP considerations apply, bring QA and validation partners into decisions early, and help translate their requirements into practical engineering approaches.
- Set technical direction and raise the bar: review designs, mentor engineers and other builders, and build the guardrails and automation that let the whole organization move fast safely.
Requirements
- 7+ years of experience building production software, including hands-on experience shipping software for use in a clinical trial.
- Familiarity with clinical systems and data flows and understand the operational realities of delivering software into an active trial environment.
- Familiarity with software delivery in a regulated or controlled environment, including concepts such as GxP/GCP, computer system validation, requirements traceability, audit trails, electronic signatures, and change control.
- Ability to translate regulatory requirements into software that is both compliant and well engineered.
- Solid distributed systems and cloud fundamentals (AWS, GCP, or Azure).
- Experience building with AI tools daily — LLMs, agentic workflows, retrieval pipelines — and interest in bringing them into regulated clinical work responsibly.
- Track record of technical ownership at senior scope: multi-quarter efforts, cross-functional dependencies, and designs that other engineers built on.
- Excellent communicator with non-engineers.
- Comfortable with ambiguity.
Skills
- AI tools
- LLMs
- Agentic workflows
- Retrieval pipelines
- Distributed systems
- Cloud fundamentals (AWS, GCP, or Azure)
Location
- New York City metro area
- Boston metro area
- Research Triangle (NC)
- San Francisco Bay Area
Work Type
- Hybrid
Experience Level
- Senior
Salary/Compensations
- $213,500 - $267,000
Benefits
- Equity
- Comprehensive benefits
- Generous perks
About the Company
- Formation Bio is a tech and AI driven pharma company focused on efficient drug development.
- They build technology platforms, processes, and capabilities to accelerate drug development and clinical trials.
- The company partners, acquires, or in-licenses drugs to develop programs past clinical proof of concept.
- Formation Bio was founded in 2016 as TrialSpark Inc.
- Investors include a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.
- Their values are the driving force behind their mission to revolutionize the pharma industry.
Equal Opportunity
- Formation Bio is committed to building a diverse and inclusive team.
- They 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.