Clinical Performance Evaluation Lead

Clinical Performance Lead (IVD / Immunoassays)

Location: Hybrid
Sector: In Vitro Diagnostics / Medical Devices

A dynamic company operating at the forefront of In Vitro Diagnostic (IVD) immunoassay development has an exciting opening for a Clinical Evaluation Performance Lead. This is a senior, hands on role with strategic responsibility for the design, delivery, and oversight of clinical performance evaluation studies in line with IVDR (2017/746), FDA, and international regulatory requirements.

This position will suit an experienced clinical research professional who enjoys operating at the interface of clinical science, regulatory strategy, and customer delivery, and who is motivated by generating robust clinical evidence that enables safe and effective diagnostics to reach patients.

The Role

As Clinical Performance Lead, you will take ownership of multiple clinical performance evaluation studies across diverse therapeutic areas, providing leadership from study design through to final reporting and regulatory submission. You will build strong partnerships with clinical sites, investigators, CROs, and customers, while ensuring studies are delivered to the highest standards of GCP, quality, and compliance.

Reporting into senior Quality & Regulatory leadership, you will play a visible role in shaping clinical strategy and supporting both new product development and customer led programmes.

Key Responsibilities

• Lead the design, management, and delivery of IVD clinical performance evaluation studies
• Provide strategic and operational oversight of multi site, multi study clinical programmes
• Ensure full compliance with GCP, IVDR, FDA, and international regulations
• Manage clinical sites, principal investigators, and CROs, including contracts and budgets
• Oversee patient recruitment strategies, timelines, and study risks
• Author and review clinical protocols, reports, summaries, and regulatory documentation
• Coordinate ethics committee and regulatory authority submissions and approvals
• Collaborate closely with R&D, Analytical Development, Regulatory, Quality, and Medical teams
• Support customer interactions, proposals, and scientific/regulatory discussions
• Drive continuous improvement in clinical operations, quality systems, and processes
• Oversee clinical data integrity, data management, and interpretation of results

Required Experience & Qualifications Essential

• Degree in Life Sciences, Medicine, Nursing, or equivalent clinical background
• Experience in clinical research within IVD or medical devices
• Strong working knowledge of GCP and clinical regulatory requirements
• Proven experience designing and managing clinical studies end to end
• Solid understanding of IVDR 2017/746, FDA, and international clinical study expectations
• Experience managing clinical sites, investigators, and external partners
• Demonstrated project management capability across complex clinical programmes

Desirable

• Advanced degree (MSc, PhD, MD)
• Background in a GCP compliant CRO, diagnostics, or pharma environment
• Experience with point of care and/or molecular diagnostics
• Exposure to statistical analysis and clinical data interpretation
• Line management, mentoring, or leadership experience
• Clinical research certification (ACRP, SoCRA, or equivalent)
• Experience with EDC systems and medical device QMS

Key Attributes

• Highly organised, analytical, and detail oriented
• Confident communicator with the ability to influence cross functional stakeholders
• Comfortable operating in a fast paced, highly regulated environment
• Solutions focused, adaptable, and customer oriented
• Willing to travel occasionally for site visits, audits, and meetings

Why Apply

This is an opportunity to take a high impact clinical leadership role within a progressive diagnostics organisation committed to innovation, quality, and patient benefit. You will have genuine influence over clinical strategy, regulatory success, and customer outcomes in a growing and highly regulated sector.