# Senior Software Engineer II, Trial Engine

**Company:** [Formation Bio](https://hotfix.jobs/companies/formation-bio)
**Location:** New York, NY, Boston, MA
**Role:** Fullstack Engineering
**Salary:** $214k – $267k/yr
**Experience:** 7+ years
**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
**Posted:** 2026-08-31

> 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.

## Job Description

## 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.

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