Senior Software Engineer II, Trial Engine

Senior Software Engineer II, Trial Engine

New York, NY;
Boston, MA

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

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as Trial Spark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.

Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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.

• 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…