Responsable principal des affaires cliniques

Enjoy the flexibility of a hybrid work schedule Enjoy the flexibility of a hybrid work schedule allowing 2 days PW home working, collaborating closely with colleagues in our Rolle, Switzerland corporate office. 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. You will have direct input to our mission to democratize data‑driven medicine for the ultimate benefit of cancer and rare disease patients across the globe. Your Mission As Clinical Affairs Lead / Senior Clinical Affairs Manager, you will own the clinical performance strategy for validation work, partnering closely with internal stakeholders and external partners to design and deliver clinical performance studies in an IVD and molecular diagnostics context. This is an individual contributor role with significant seniority and visibility. You will work cross‑functionally with Regulatory Affairs, Clinical Operations, CROs, consultants, notified bodies, and biopharma partners, bringing the clinical and scientific expertise needed to shape study design, clinical risk evaluation, and clinical evidence requirements. The value you add Design and deliver clinical performance study strategy, protocols, and reports for IVDR and CDx programs. Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design. Partner closely with Regulatory Affairs on technical files, notified body interactions, and clinical evidence questions. Govern CRO activity day to day, reviewing outputs with a critical eye and holding external partners accountable for delivery. Contribute to the development of a strong validation function, working alongside analytical performance and clinical operations colleagues. Requirements Significant experience in clinical affairs, clinical operations, clinical science, or a closely related discipline within IVD or molecular diagnostics. Strong exposure to IVD and CE‑IVD environments; NGS experience is ideal, with molecular diagnostics experience as the minimum target background. Experience designing or contributing to clinical performance studies, including protocols, clinical evidence strategy, and study reporting. Experience managing CROs or strategic external partners, including reviewing outputs and driving accountability. Experience working closely with regulatory teams on technical files, notified body interactions, or clinical evidence requirements. Senior stakeholder presence, with the ability to engage confidently with CROs, consultants, regulatory partners, notified bodies, and biopharma partners. Experience with companion diagnostics, biopharma partnerships, NGS‑based diagnostics, or IVDR clinical performance documentation and submissions would be valuable. A clinical or scientific background that enables you to critically assess study design, risk, and evidence requirements. Benefits Sickness and Accident coverage through Helsana Meal Vouchers at 90CHF PM with our partner cafeteria A fun and engaging work environment, with Rest Entertainment space, full stocked free coffee machine and free fruit/snacks Free parking in an easy to access location A strong social committee whose purpose is to make SOPHiA GENETICs both enjoyable as well as rewarding As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally Starting Date: ASAP Location: Rolle, CH Contract: Permanent #J-18808-Ljbffr