CV-Library
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