Senior Software Engineer II - AI-Driven Clinical Trials (Hybrid)
Formation Bio
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Benefits offered by this job
Job summary
Formation Bio is seeking a Senior Software Engineer II to own and advance production software for active clinical trials in a regulated setting. You will integrate diverse clinical systems, manage data flows, and ensure auditability and compliance while delivering reliable, scalable solutions across trial sites.
You will lead technical decisions, mentor peers, and partner with Clinical Operations, Data Management, Regulatory, QA, and Infrastructure to ship and operate differentiated software
Qualifications
- 7+ years of experience building production software in a regulated environment.
- Knowledge of GxP/GCP, computer system validation, audit trails, and change control.
- See regulation as a design constraint to improve software in clinical contexts.
- Strong builder with distributed systems, cloud fundamentals, and long-term direction.
- Daily use of AI tools and interest in bringing them into regulated work.
Responsibilities
- Design, deliver, and run production software for live clinical trials.
- Integrate with clinical systems (EDC, CTMS, eTMF) and ensure data provenance.
- Own trial-specific domain logic and collaborate with data engineering and QA teams.
- Set technical direction, mentor engineers, and implement robust guardrails.
Skills
Tools
Job description
Formation Bio is seeking a Senior Software Engineer II to own and advance production software for active clinical trials in a regulated setting. You will integrate diverse clinical systems, manage data flows, and ensure auditability and compliance while delivering reliable, scalable solutions across trial sites.
You will lead technical decisions, mentor peers, and partner with Clinical Operations, Data Management, Regulatory, QA, and Infrastructure to ship and operate differentiated software
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