Own the clinical performance strategy for validation work
Partner closely with internal stakeholders and external partners to design and deliver clinical performance studies in an IVD and molecular diagnostics context
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

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.

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
Direct interaction and exposure to senior leadership and our executive team locally

Senior Clinical Affairs Manager

Key skills