Ivd Development & Validation Lead

Are you an experienced IVD professional specializing in NGS-based IVD and CDx products? Ready to take on impactful new projects at the forefront of precision medicine? If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Bioinformatic Product Development team as our IVD Development & Validation Lead, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide. This role is a hybrid opportunity, requiring 3 days onsite our corporate office in Rolle, CH. Our Mission We believe there is a smarter, more data-driven way to make decisions in healthcare and our cloud-native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. 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. Your Mission SOPHiA GENETICS has a strong NGS platform, established pharma partnerships, and a track record of delivering CE-IVD certified products. We are now scaling our CDx and CTA portfolio and investing in the IVD development and validation expertise to match that ambition, including under the more demanding requirements of IVDR and FDA. This role sits within a cross-functional organization, working closely with colleagues across bioinformatics, NGS assay development, regulatory, and clinical operations. Depending on your background, you will own the validation program for one or more CDx/CTA projects or take broader technical ownership across the full development lifecycle, from assay and bioinformatics pipeline development through V&V and the full regulatory evidence package. We work with urgency and purpose to meet the demands of patients and our pharma partners. This means knowing what a study needs to demonstrate, designing it accordingly, and not adding work that does not contribute to that goal. It also means building processes and standards that hold up as the portfolio grows.