Senior Software Engineer II, Trial Engine

Formation Bio•Boston, NY

5d•Hybrid

About The Position

Clinical trials are where drug development actually gets slow and expensive. Sites take months to activate. Data arrives late, in fragments, from a dozen systems and vendors that don't talk to each other. People spend their weeks reconciling spreadsheets instead of making decisions. The Trial Execution team exists to fix that, and this role is a senior seat on it. The constraint that makes this interesting: our trials run in a regulated space. Systems that touch patient safety or trial integrity are GxP-relevant, which means computer system validation, 21 CFR Part 11, audit trails, traceability, and a real burden of proof that the software does what it claims. Most engineers treat that as a wall. We think it's a design problem — and we think the companies that figure out how to run AI inside those constraints, rather than around them, will develop drugs faster than anyone else. We're looking for someone who finds that genuinely exciting rather than merely tolerable. You'll build the systems that run active trials: integrations with EDC and other clinical systems, site selection and activation, clinical data flows, monitoring and signal detection, timeline reconciliation across CROs and vendors. Increasingly that work is agentic — agents reading source data directly to surface discrepancies, signals, and tasks that a human would otherwise have hunted for by hand. Designing that so it's auditable, provenance-tracked, and appropriately human-in-the-loop is the hard and interesting part of the job. As a Senior Software Engineer II, you'll be a senior individual contributor and the technical owner of a meaningful slice of our Trial Execution platform. You'll drive work across multiple quarters, from identifying the opportunity and shaping the technical approach through shipping and operating differentiated software used in active trials. You'll partner directly with Clinical Operations, Data Management, Regulatory, QA, Data Engineering, and Infrastructure to develop the systems, integrations, data flows, and controls required to put that software into production. You will bring enough familiarity with regulated delivery to identify potential GxP implications early and engage the right QA and validation experts.

Requirements

7+ years of experience building production software, including hands-on experience shipping software for use in a clinical trial.
You are familiar with clinical systems and data flows and understand the operational realities of delivering software into an active trial environment.
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.
You do not need to be the organization's regulatory expert, but you should know when these considerations matter and how to work effectively with QA and validation partners.
You see regulation as a design constraint to work within, not a reason systems cannot improve.
You can help translate regulatory requirements into software that is both compliant and well engineered.
A 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. This is a core part of the role, not a side interest.
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. You can sit with a clinical operations lead or a QA director, understand their world, and align on an approach.
Comfortable with ambiguity. Our trial portfolio and our approach both change; the roadmap you inherit will not be the one you finish.

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.