Vice President Research And Development

About the role

Spencer Rigby is recruiting for a clinical-stage point-of-care diagnostics company developing a rapid PoC test to risk-stratify patients in a high-acuity clinical setting. The company was founded and is managed by practising clinical and scientific leaders in assay development. Its product is at an advanced development stage, with a clinically validated concept and a CDMO partnership in place.

The role will bridge scientific discovery and a commercially ready point-of-care diagnostic product, coordinating the founding scientific team, the CDMO and regulatory consultants. The goal is to progress the product from its current pre-commercial stage through regulatory clearance and market launch.

Responsibilities

• Own end-to-end development, from 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 product development milestones and deliverables.
• Oversee CDMO-based scientists and ensure alignment with product specifications and timelines.
• Lead regulatory strategy and execution with the company's regulatory consultants.
• Drive the product toward FDA clearance (510(k).
• Establish and maintain quality systems appropriate to a...

Key facts

• The product is a rapid point-of-care test intended to risk-stratify patients in a high-acuity clinical setting.
• The role owns development from assay optimisation through manufacturing readiness.
• The work involves coordination with the founding scientific team, the CDMO and regulatory consultants.