Senior Clinical Affairs Manager

Senior Clinical Affairs Manager

SOPHiA GENETICS

Rolle, Switzerland

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

We know every background is different, but to be best set for success we see you bringing:

• 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.