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