Chapter Lead, Head of SBX Assays

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As Chapter Lead and Head of SBX Assays, you will drive the clinical translation of cutting-edge technology into RUO and regulated products that redefine the standard of care in precision oncology and genetics. You will provide strategic and technical leadership to define the next generation of oncology diagnosticsu2014ranging from multi-cancer early detection to ultra-sensitive MRD monitoring. You will lead the end-to-end evolution of novel clinical solutions, bridging the gap between novel workflow tools and high-throughput commercial implementation. Your leadership will ensure that our assays are not just innovative, but are robust, scalable, and clinically validated to meet the most stringent regulatory standards (PMA/IVD). Key Responsibilities: + Oncology Product Roadmap : Partner with Executive Leadership and Business teams to identify high-value clinical unmet needs and translate them into a multi-year technology roadmap. + Strategic Execution : Drive development of proprietary oncology assays, including defining performance requirements (LOD, sensitivity, specificity) that exceed current market standards. + Product Realization & Scale : Oversee the critical transition of assays from R&D into a CLIA/CAP or IVD-regulated environment, ensuring manufacturability and operational scalability. + Assay Innovation & De-risking : Implement and de-risk emerging technologies for use in clinical applications (e.g., epigenetics, fragmentomics, multi-omics). + Regulatory : Partner with Regulatory and Quality teams to design analytical and clinical validation studies (LoD, LoB, Precision) that meet FDA/PMA standards for Breakthrough Device designations. + Evidence Generation & KOL Engagement : Help define the clinical evidence strategies required for medical utility based on high-level scientific exchange with top-tier academic centers and biopharma partners. + Bioinformatics Integration : Architect the interface between wet-lab chemistry and Computational Biology to optimize

Created: 2026-04-13