Director R&D – Clinical Assay/CDx Development

Job description

Overview Waters Biosciences is a world leader in providing innovative flow cytometry diagnostic and research tools to laboratory professionals, clinicians, and clinical/life science researchers The Director of R&D – Clinical Assay & CDx Development will serve as a senior technical and scientific leader responsible for advancing flow cytometry–based clinical assays and companion diagnostics (CDx) from early concept through validation and commercialization. This role is ideal for an individual with deep, hands‑on experience in clinical assay development within a regulated IVD environment, who can provide leadership across assay design, analytical validation, regulatory strategy, and cross‑functional execution. The Director will play a critical role in ensuring scientific rigor, regulatory compliance, and clinical relevance while shaping the long‑term diagnostic innovation strategy for Waters Biosciences. Responsibilities: - Serve as the technical and scientific authority for clinical flow cytometry assay and CDx development, providing guidance from feasibility through commercialization. - Lead and advise on assay design, optimization, analytical performance characterization, verifica...