Senior Software Engineer II

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.