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Senior Software Engineer II, Trial Engine

Formation · Boston · On-site

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About Formation

Start your business journey with Formations. Register your LLC in just four quick steps, and discover a simpler way to form and manage your business. Backed by a16z.

About the role

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. Found on 1752vc Careers, the job board for startup and VC roles.

More about this role

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...

Read the full posting on Formation's site ↗

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