Senior Software Engineer II, Trial Engine

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

The Senior Software Engineer II, Trial Engine role is a senior individual contributor position on the Trial Execution team. You will build systems that run active trials, including integrations with EDC and other clinical systems, site selection and activation, clinical data flows, monitoring and signal detection, and timeline reconciliation across CROs and vendors.

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 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.
• Strong builder: clean, maintainable code, solid distributed systems and cloud fundamentals (AWS, GCP, or Azure), and the judgment to know when to build for the next five years and when to build for next week.
• You build with AI tools daily , LLMs, agentic workflows, retrieval pipelines , and you're actively interested in how to bring 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.

Total Compensation Range: $213,500 - $267,000