IVD Development & Validation Lead

Own the design and execution of validation programs for NGS-based IVD and CDx products, covering analytical performance, clinical performance, usability, and stability. Design studies that are fit for purpose: the right methodology, acceptance criteria, and statistical approaches based on what needs to be demonstrated and the applicable regulatory context, drawing on relevant guidance (CLSI, professional standards, etc) and your own experience. Handle the statistical aspects of V&V studies across the full range of study types - you know the standard approaches, when to apply them, and how to establish defensible methods. Produce DHF-ready documentation, written clearly enough to be reviewed without extensive back-and-forth. Build reusable validation frameworks, templates, and SOPs that can be applied consistently across programs. Be accountable for the technical success of CDx/CTA development programs end-to-end, from assay and bioinformatics pipeline development through verification, validation, and submission-ready regulatory evidence. Connect the development, validation, and regulatory sub-teams, to ensure efficient project delivery and effective project risk mitigation. Define the regulatory evidence strategy in collaboration with the Regulatory Lead: what is required, what is sufficient, what is not needed. Design the processes and standards that allow a growing diagnostics portfolio to be delivered consistently and efficiently across programs. Work closely with NGS scientists, bioinformaticians, regulatory, quality, and product colleagues across a highly cross-functional environment. Contribute to developing IVD capability across the organization and mentoring junior scientists where relevant.

SOPHiA GENETICS is the creator of SOPHiA DDM™, a cloud-based platform for analyzing complex multimodal data and generating insights that help healthcare institutions make faster, better informed decisions. We work primarily in oncology and inherited disorders, where integrating genomic and phenotypic data is critical for clinical decision-making, research, and drug development. Our data-sharing methodology connects researchers and clinicians globally, supporting a community-driven approach to precision medicine. Our mission is to democratize data-driven medicine and ensure that every patient has access to the best possible diagnosis.

• Hands-on experience developing and validating NGS-based IVDs in a clinical diagnostic or CDx context.

• A thorough understanding of IVD analytical and clinical validation methodology: how to design studies that are fit for purpose, what guidance frameworks apply and when, and how to make and defend scope decisions.

• Working knowledge of FDA IVD regulatory pathways (510(k), De Novo, PMA, CTA/IUO) and/or EU IVDR, sufficient to design a validation program that holds up under regulatory review.

• Good working knowledge of statistics as applied to IVD V&V: familiar with the standard approaches across the main study types, and able to establish pragmatic, defensible methods. Deeper statistical expertise is a plus.

• Experience working within design controls and contributing to a Design History File.

• Clear, precise technical writing. Protocols and reports that are complete and reviewable without the need for extensive edits.