Senior Software Engineer II, Trial Engine
Senior individual contributor owning a major part of a clinical-trial execution platform, including regulated software, clinical-system integrations, and AI-native workflows. Requires 7+ years building production software, clinical-trial experience, cloud and distributed-systems expertise, and familiarity with validated delivery.
About the job
Responsibilities
- Own the design, delivery, and operation of production software used in live clinical trials, from site startup and activation through data collection, monitoring, and close-out.
- Coordinate clinical, regulatory, data, and infrastructure partners to take software from technical design through validated use.
- Build within a validated software development lifecycle (SDLC), translating validation requirements into traceable, testable software with QA and computer system validation (CSV) partners.
- Design and ship AI-native trial execution capabilities, including agents and pipelines that surface signals, discrepancies, and tasks with provenance, audit trails, and human review.
- Build integrations across EDC, CTMS, eTMF, CRO and laboratory data feeds, and safety systems.
- Own trial-specific domain logic and clinical-data software while partnering with Data Engineering on ingestion, orchestration, warehousing, quality, and governance.
- Improve tooling so trial activities can begin earlier or run in parallel.
- Identify GxP implications early and translate QA and validation requirements into practical engineering approaches.
- Set technical direction, review designs, mentor engineers, and build guardrails and automation for safe delivery.
Requirements
- 7+ years of experience building production software, including hands-on experience shipping software used 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.
- Strong coding skills with clean, maintainable software and solid distributed-systems and cloud fundamentals.
- Experience with AWS, Google Cloud, or Azure.
- Daily experience using AI tools such as LLMs, agentic workflows, and retrieval pipelines.
- Track record of senior technical ownership across multi-quarter efforts and cross-functional dependencies.
- Excellent communication with clinical operations, QA, and other non-engineering stakeholders.
- Comfort working in ambiguous and changing environments.
Compensation
- Total compensation range: $213,500–$267,000
- Equity, comprehensive benefits, and generous perks are offered.
Skills
AWS, GCP, Microsoft Azure, Distributed Systems, LLMs, Agentic Workflows, Retrieval Pipelines, Edc, Ctms, Etmf, Gxp, Computer System Validation, Audit Trails, Electronic Signatures, Change Control
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