About the Company
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Our client is a clinical-stage point-of-care diagnostics company developing a rapid PoC test to risk-stratify patients in a high-acuity clinical setting. Founded and managed by practising clinical and scientific leaders in assay development, the company is at an advanced stage of product development — commercialising a breakthrough that its founding team helped discover, backed by a leading academic medical centre.
The company is at an inflection point. The scientific foundation is world-class, the CDMO partnership is in place, and the product concept is clinically validated. What is now needed is an experienced, hands-on technical leader to bridge the gap between scientific discovery and a commercially ready point-of-care diagnostic product.
You will serve as the operational spine of the product development effort — coordinating between the founding scientific team, the CDMO, and regulatory consultants to drive the product from its current pre-commercial stage through to regulatory clearance and market launch. This is a rare opportunity to join a well-credentialed, founder-led point-of-care diagnostics company at an early stage with a clear product vision and strong financial backing.
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Key Responsibilities
- Own end-to-end development assay optimisation through manufacturing readiness
- Serve as the primary day-to-day technical interface with the CDMO and any future development partners
- Translate scientific findings and founder insights into concrete product development milestones and deliverables
- Oversee the work of CDMO-based scientists and ensure alignment with product specifications and timelines
- Lead regulatory strategy and execution in partnership with the company's regulatory consultants
- Drive the product toward FDA clearance (510(k)
- Establish and maintain quality systems appropriate to a pre-commercial IVD company
- Report directly to the CEO and collaborate closely with the CFO/COO
- Support the ongoing fundraising process with technical diligence materials and investor engagement
- Contribute to distribution partnership discussions and help shape the company's go-to-market technical strategy
- Build and scale the internal technical team as funding and growth allow
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Experience
- Significant experience in IVD product development, with specific rapid point-of-care platforms
- Track record of taking a diagnostic product from development through regulatory submission and commercial launch
- Familiarity with FDA regulatory pathways for in vitro diagnostics (510(k)
- Backgrounds from companies such as Abbott (point-of-care), Alere, Quidel, Becton Dickinson, or similar organisations are particularly relevant
- Familiarity with the relevant biomarker diagnostic space is a strong advantage
- Comfortable operating in a lean company environment where leadership requires both strategic thinking and hands-on execution
- Entrepreneurial mindset and genuine interest in improving patient outcomes in an underserved clinical area
- Willing to be based in or regularly present in the San Diego area
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Interested in learning more? Reach out directly!
Nathan@Spencer-Rigby.com
Vice President Research And Development in San Diego at Spencer Rigby
This position is listed as full time and onsite. It was posted 2 days ago.