Principal Clinical Affairs Manager

• 09 July 2026 • 100% • Indeterminate duration • Role Do you have solid experience in clinical affairs, clinical sciences, or clinical operations in the field of in vitro diagnostic medical devices (IVD) or molecular diagnostics? Have you designed clinical performance studies and developed a clinical evidence strategy in an IVDR, CE-IVD, or companion diagnostics environment? If this matches you and you are motivated by a purpose, join the SOPHiA GENETICS team as a Principal Clinical Affairs Manager and contribute to having a positive impact on outcomes for patients with cancer and rare diseases worldwide. Enjoy the flexibility of a hybrid schedule allowing 2 days of remote work per week, collaborating closely with colleagues at our headquarters in Rolle, Switzerland. Our mission ### We believe there is a smarter, more data-driven way to make healthcare decisions, and our cloud-native, AI-powered SOPHiA DDM platform makes this vision a reality every day. You will directly contribute to our mission to democratize data-driven medicine for the ultimate benefit of patients with cancer and rare diseases worldwide. Your mission ### As a Clinical Affairs Manager / Principal Clinical Affairs Manager, you will be in charge of the clinical performance strategy for validation work, collaborating closely with internal stakeholders and external partners to design and conduct clinical performance studies in an IVD and molecular diagnostics context. This is an individual contributor role with high seniority and visibility. You will work cross-functionally with regulatory affairs, clinical operations, CROs, consultants, notified bodies, and biopharmaceutical partners, providing the necessary clinical and scientific expertise to guide study design, clinical risk assessment, and clinical evidence requirements. The value you bring ### • * Design and implement the strategy, protocols, and study reports for clinical performance studies for IVDR and CDx programs. • * Define and address clinical evidence requirements, providing clinical input to product risk assessment and study design. • * Collaborate closely with regulatory affairs on technical files, interactions with notified bodies, and clinical evidence questions. • * Manage CRO activity on a daily basis, reviewing results with a critical eye and holding external partners accountable for delivery. • * Contribute to the development of a strong validation function, working alongside colleagues in analytical performance and clinical operations. • Requirements We know that every path is different, but to maximize your chances of success, we expect from you: • * Significant experience in clinical affairs, clinical operations, clinical sciences, or a related discipline in the IVD or molecular diagnostics field. • * Strong exposure to IVD and CE-IVD environments; NGS experience is ideal, with molecular diagnostics experience as a minimum requirement. • * Experience in designing or contributing to clinical performance studies, including protocols, clinical evidence strategies, and study reports. • * Experience in managing CROs or strategic external partners, including reviewing results and holding them accountable. • * Experience working closely with regulatory teams on technical files, interactions with notified bodies, or clinical evidence requirements. • * Presence with senior stakeholders, with the ability to engage confidently with CROs, consultants, regulatory partners, notified bodies, and biopharmaceutical partners. • * Experience in companion diagnostics, biopharmaceutical partnerships, NGS-based diagnostics, or clinical performance documentation and IVDR submissions would be an asset. • * A clinical or scientific background allowing you to critically evaluate study design, risks, and clinical evidence requirements. • Benefits You will join an organization that puts the patient at the heart of every decision and action, driven by a purpose as we pursue exponential growth. Business recognitions and awards include: • * Among the top 10 most innovative companies in the world • * Among the top 50 most intelligent companies in the world • * 100 best places to work in Boston • * Top 10 European tech startups • * Top 10 European biotech startups to watch • * Top 25 East Coast biotechs to watch • Our benefits package is comprehensive but varies by country according to local norms and laws. You can discuss it in detail with us, but in brief: • * Health and accident coverage via Helsana • * Meal tickets at 90 CHF per month with our partner cafeteria • * A pleasant and engaging work environment, with a rest & entertainment area, a well-stocked free coffee machine, and free fruits/snacks • * Free parking in an easily accessible location • * A dynamic social committee whose mission is to make SOPHiA GENETICS both enjoyable and rewarding • * As a global headquarters, you will have direct interaction and exposure to senior leadership and our local executive team • Our DNA Like the strands of DNA itself, SOPHiA