Clinical Validation Lead – Diagnostics Assay

Overview

Pictura Bio is a well-funded University of Oxford spin-out developing a novel diagnostic platform for rapid pathogen detection. Our technology combines fluorescence microscopy with automated image analysis and machine learning to identify pathogens in seconds. The platform is being translated into clinical diagnostic products, initially focused on respiratory infections, with broader applications across infectious disease.

Role Purpose

The Clinical Validation Lead will be responsible for designing, executing, and overseeing clinical and analytical validation of Pictura Bio’s diagnostic assays. You will lead validation strategy from late-stage development through clinical evaluation, ensuring studies are scientifically robust, regulator-ready, and aligned with the intended clinical use. This role is ideal for someone with hands-on experience validating diagnostic assays in regulated environments, particularly US LDTs, but experience with FDA-cleared/approved, UK, or EU IVD pathways is also highly relevant. You will work closely with assay development, data science, regulatory, and external clinical partners.

Major Accountabilities

• Lead the design and execution of analytical and clinical validation studies for diagnostic assays
• Define validation plans covering precision, accuracy, sensitivity/specificity, LoD, reproducibility, interference, and cross-reactivity
• Ensure validation studies are aligned with intended use, clinical claims, and regulatory expectations
• Oversee clinical sample selection, handling, and testing in collaboration with partner laboratories and CROs
• Support validation of Laboratory Developed Tests (LDTs), particularly within the US regulatory framework
• Contribute to validation supporting FDA (e.g. De Novo / 510(k)), UKCA, or CE-IVD pathways where applicable
• Review and approve protocols, reports, and data summaries for internal and external use
• Work with data science teams to ensure clinical performance metrics and analyses are appropriate and traceable
• Interface with regulatory and quality teams to support technical files, submissions, and audits
• Manage external stakeholders (clinical sites, reference labs, CROs) involved in validation activities
• Clearly communicate validation strategy, results, and risks to senior leadership

Ideal Background

Education

• PhD, MD, PharmD, or MSc in a relevant discipline (e.g. Clinical Sciences, Biomedical Sciences, Molecular Biology, Immunology, Microbiology)

Experience

• Demonstrated experience clinically validating diagnostic assays
• Experience with assays such as immunofluorescence, molecular diagnostics, NGS / optical sequencing (e.g. Illumina), or imaging-based diagnostics
• Experience developing or validating US Laboratory Developed Tests (LDTs) is highly desirable
• Experience supporting FDA-cleared/approved assays (De Novo, 510(k), PMA) or UK/EU IVD pathways is advantageous
• Experience working with clinical samples (e.g. respiratory samples, blood, urine, swabs)
• Experience collaborating with hospital labs, reference labs, or CROs

Skills

• Deep understanding of diagnostic validation principles and study design
• Strong knowledge of clinical performance metrics and statistical interpretation
• Familiarity with regulatory and quality frameworks (e.g. CLIA, CAP, ISO 13485, ISO 15189)
• Ability to translate clinical requirements into practical validation studies
• Strong documentation, reporting, and review skills
• Excellent communication skills, including interaction with clinicians, regulators, and executives

Desirable Personal Attributes

• Highly organised and detail-oriented, with a strong quality mindset
• Comfortable taking ownership of complex, multi-stakeholder validation programmes
• Scientifically rigorous but pragmatic in balancing timelines and regulatory expectations
• Confident communicator who can explain validation decisions clearly
• Comfortable working in a fast-moving, scaling diagnostics company