Senior Program Leader (IVD/CDx)

SOPHiA GENETICS is building a cloud‑native, AI‑driven diagnostics platform that aims to make data‑centric care accessible for cancer and rare‑disease patients worldwide. As a Senior Program Leader within the Diagnostics Solutions team, you will steer one or more in‑vitro diagnostic (IVD) or companion‑diagnostic (CDx) initiatives, working from the company’s Rolle, Switzerland hub while enjoying a hybrid schedule that permits two days of remote work each week and offers relocation support when needed. Your daily focus will be on shaping and executing the end‑to‑end strategy for programs that span clinical‑trial assays, tumor‑profiling tests, CDx and software‑as‑a‑medical‑device projects. You will align analytical and clinical validation plans with biopharma drug‑development milestones, act as the primary liaison for partner companies, and drive governance activities such as portfolio reviews, design reviews and joint steering committees. Coordinating bioinformatics, assay development, clinical operations, regulatory affairs, quality, manufacturing and product management, you will guide each effort from concept through verification, regulatory submission and market launch while monitoring timelines, budgets, risks and resource allocation. The role requires at least eight years of experience in diagnostic product development or program ownership, including three years leading cross‑functional initiatives. A proven record of taking an IVD or CDx through FDA approval, CE marking or a pivotal clinical trial is essential, as is deep expertise in assay design, bioinformatics, analytical and clinical validation, and global regulatory pathways. Candidates must hold a bachelor’s degree; a PhD or master’s in a relevant life‑science discipline is preferred. Strong budgeting, resource‑planning, communication, negotiation and conflict‑resolution abilities are also mandatory. Preferred assets include hands‑on work with diagnostic platforms, oncology therapeutic‑area exposure, and familiarity with EU IVDR and FDA requirements. The position offers a vibrant office environment with free parking, meal vouchers, stocked coffee and snack stations, and an active social committee. Direct interaction with senior leadership and a reputation as a top‑ranked innovative biotech further enrich the opportunity.