Clinical Validation Lead - Diagnostics Assay

Job Description OverviewPictura 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 PurposeThe Clinical Validation Lead will be responsible for designing, executing, and overseeing clinical and analytical validation of Pictura Bios 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 AccountabilitiesLead the design and execution of analytical and clinical validation studies for diagnostic assaysDefine validation plans covering precision, accuracy, sensitivity/specificity, LoD, reproducibility, interference, and cross-reactivityEnsure validation studies are aligned with intended use, clinical claims, and regulatory expectationsOversee clinical sample selection, handling, and testing in collaboration with partner laboratories and CROsSupport validation of Laboratory Developed Tests (LDTs), particularly within the US regulatory frameworkContribute to validation supporting FDA (e.g. De Novo / 510(k)), UKCA, or CE-IVD pathways where applicableReview and approve protocols, reports, and data summaries for internal and external useWork with data science teams to ensure clinical performance metrics and analyses are appropriate and traceableInterface with regulatory and quality teams to support technical files, submissions, and auditsManage external stakeholders (clinical sites, reference labs, CROs) involved in validation activitiesClearly communicate validation strategy, results, and risks to senior leadershipIdeal BackgroundEducationPhD, MD, PharmD, or MSc in a relevant discipline (e.g. Clinical Sciences, Biomedical Sciences, Molecular Biology, Immunology, Microbiology)ExperienceDemonstrated experience clinically validating diagnostic assaysExperience with assays such as immunofluorescence, molecular diagnostics, NGS / optical sequencing (e.g. Illumina), or imaging-based diagnosticsExperience developing or validating US Laboratory Developed Tests (LDTs) is highly desirableExperience supporting FDA-cleared/approved assays (De Novo, 510(k), PMA) or UK/EU IVD pathways is advantageousExperience working with clinical samples (e.g. respiratory samples, blood, urine, swabs)Experience collaborating with hospital labs, reference labs, or CROsSkillsDeep understanding of diagnostic validation principles and study designStrong knowledge of clinical performance metrics and statistical interpretationFamiliarity with regulatory and quality frameworks (e.g. CLIA, CAP, ISO 13485, ISO 15189)Ability to translate clinical requirements into practical validation studiesStrong documentation, reporting, and review skillsExcellent communication skills, including interaction with clinicians, regulators, and executivesDesirable Personal AttributesHighly organised and detail-oriented, with a strong quality mindsetComfortable taking ownership of complex, multi-stakeholder validation programmesScientifically rigorous but pragmatic in balancing timelines and regulatory expectationsConfident communicator who can explain validation decisions clearlyComfortable working in a fast-moving, scaling diagnostics company

Created: 2025-12-31