Senior Software Engineer II - AI for Regulated Trials

Formation; Town of Boston (NY); Hybrid; USD 214,000 - 267,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Hybrid work model

Job summary

Formation Bio in New York City and Boston seeks a Senior Software Engineer II to own production software for active clinical trials, integrating with EDC and other clinical systems and shaping the technical approach.

You will collaborate with Clinical Operations, Data Management, Regulatory, QA, Data Engineering, and Infrastructure to deliver auditable, compliant software in a regulated space, focusing on AI-native pipelines and end-to-end trial support.

Qualifications

• 7+ years of experience building production software for clinical trials or regulated environments.
• Familiarity with GxP/GCP concepts, electronic signatures, and validation practices.
• Experience with cloud platforms (AWS, GCP, Azure) and modern distributed systems.
• Experience embedding AI-like tools and agentic pipelines into regulated software.
• Strong communication skills and ability to work with non-engineers and cross-functional teams.

Responsibilities

• Drive design, delivery, and operation of production software used in live clinical trials from site startup to data collection and close-out.
• Coordinate cross-functional dependencies with clinical, regulatory, data, and infrastructure teams.
• Translate validation requirements into testable software and improve engineering workflows for compliant delivery.
• Design and ship AI-native trial execution capabilities with provenance and audit trails for regulated contexts.
• Build integrations across clinical systems (EDC, CTMS, eTMF, CRO data feeds) to form a coherent trial picture.
• Own the trial-specific domain logic and collaborate with data engineering on ingestion, orchestration, and governance.

Skills

Production software

Regulated environment

Cloud fundamentals

AI tooling in regulated context

Mentoring & leadership

Effective communicator

Tools

AWS

GCP

Azure

Job description

Formation Bio in New York City and Boston seeks a Senior Software Engineer II to own production software for active clinical trials, integrating with EDC and other clinical systems and shaping the technical approach.

You will collaborate with Clinical Operations, Data Management, Regulatory, QA, Data Engineering, and Infrastructure to deliver auditable, compliant software in a regulated space, focusing on AI-native pipelines and end-to-end trial support.