Technical Advisor

Company overview

Bowlyn ensures clinical operations in emerging biotechs run seamlessly, so groundbreaking science can reach patients. By optimizing study execution and accountability from IND through Phase 3, Bowlyn empowers teams to keep trials on track and deliver impactful results.

Learn more at bowlynbio.com.

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Role description

We're an early-stage clinical operations services + software company building infrastructure for emerging biotech sponsors. Our product captures audit-trail-grade records of clinical trial activity and the kind of documentation that has to hold up to FDA inspection and, down the road, formal validation.

We're looking for a senior engineer or architect to serve as a fractional technical advisor: review our build at key milestones, pressure-test the foundational decisions, and flag risks before they're baked in. Someone who can independently review the architecture decisions that are expensive to get wrong; specifically, around audit-trail integrity, data-schema durability, and the path to eventual regulatory validation. You won't be writing code or managing anyone. You'll be the independent technical judgment a non-technical founding team needs.

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What you'd actually do

• An in-depth initial architecture review of our current build (a portal-based, AWS-hosted, AI-assisted product) and our planned next build, delivered as a prioritized written assessment of risks and recommendations
• Ongoing independent judgment at key build decision points thereafter — milestone-triggered rather than a standing weekly commitment
• Specifically evaluate: audit-trail design, data-schema durability, security and access-control posture, and the realistic path to 21 CFR Part 11 validation
• Talk directly with our engineer, peer-to-peer, on the consequential calls

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What you must have

• Experience shipping regulated clinical, medical, or healthcare software - not healthcare-adjacent, but systems built under real compliance requirements
• Working knowledge of what 21 CFR Part 11 / GxP demand of system design (audit-trail integrity, e-records durability, access control) applied as an architect, not as a validation/QA reviewer
• Strong architecture judgment: you've owned or led foundational technical decisions, not just implemented to spec
• Hands-on architectural judgment on a live AWS application stack — you can sit with our engineer and challenge specific design decisions (hosting, auth, data isolation, audit logging, key management), not just review documentation
• Ability to give clear, prioritized, written feedback a non-technical founder can act on

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Nice to have

• Background at a clinical-software or digital-health company that went through FDA submission or validation
• Experience with AI/LLM integration in regulated contexts

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Logistics

• Remote
• Compensation is competitive and structured around the engagement
• The engagement begins with a paid, scoped initial review, and requires a signed NDA and IP-assignment agreement before access to internal materials
• Engagement begins ASAP as we have an architectural decision point coming up in mid-July and want our advisor engaged and through the initial review before then
• This role is open to U.S. residents only. We are not able to sponsor visas at this time
• Direct applicants only. We are not engaging with recruiters or staffing agencies for this role and unsolicited submissions will not be considered
• Independent contractor engagement; no W-2 employment

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About Bowlyn

We're a small, founder-led company building real infrastructure for a real problem: emerging biotech sponsors hold regulatory accountability for clinical trials they often can't structurally meet with the tooling they have today. We're building what they actually need - operator-grade, sponsor-controlled, inspection-ready. The team is small, the work is serious, and the bar for what we ship is set by what regulatory bodies will eventually ask.

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How to Apply

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