About the Company:
----------------------------------------------------------------------------- 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. ----------------------------------------------------------------------------- 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 ----------------------------------------------------------------------------- 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 ----------------------------------------------------------------------------- Interested in learning more? Reach out directly!
