Senior Clinical Affairs Manager

SOPHiA GENETICS seeks a Senior Clinical Affairs Manager in Rolle, CH, to lead clinical performance strategy for IVDR and CDx programs in a hybrid role.

This individual contributor position carries high visibility and seniority within the organization. The primary focus is owning the clinical performance strategy for validation work, ensuring robust evidence generation. The role directly supports the company’s mission to improve outcomes for patients with cancer and rare diseases globally.

Responsibilities

• Develop and execute strategies, protocols, and reporting for clinical performance studies across IVDR and companion diagnostics (CDx) programs.
• Establish clinical evidence requirements and provide expert input on product risk assessments and study designs.
• Collaborate closely with Regulatory Affairs to manage technical files, handle notified body interactions, and resolve clinical evidence queries.
• Oversee daily CRO operations, critically reviewing deliverables and ensuring external partners meet accountability standards.
• Help build a robust validation function by coordinating with analytical performance and clinical operations teams.

Requirements

• Extensive background in clinical affairs, operations, or science, specifically within IVD or molecular diagnostics.
• Proven experience in IVD and CE-IVD settings; NGS exposure is preferred, while molecular diagnostics experience is the baseline requirement.
• Demonstrated ability to design or contribute to clinical performance studies, including writing protocols, defining evidence strategies, and producing reports.
• Track record of managing CROs or strategic external partners, with a focus on reviewing outputs and enforcing accountability.
• Experience collaborating with regulatory teams on technical documentation, notified body communications, and evidence requirements.
• Strong stakeholder management skills, capable of engaging confidently with consultants, regulatory bodies, notified bodies, and biopharma partners.
• A clinical or scientific foundation that allows for critical evaluation of study designs, risks, and evidence needs.

Nice to have

• Prior work with companion diagnostics, biopharma partnerships, NGS-based diagnostics, or IVDR clinical performance documentation and submissions.

What the company offers

• Hybrid work model permitting two days per week from home.
• Health coverage for sickness and accidents via Helsana.
• Meal vouchers valued at 90 CHF per month through the partner cafeteria.
• Access to rest and entertainment areas, along with complimentary coffee, fruit, and snacks.
• Free parking in a conveniently located facility.
• Active social committee focused on creating an enjoyable and rewarding workplace culture.
• Direct exposure to senior leadership and the local executive team.

About the company

SOPHiA GENETICS operates with a purpose-driven mindset, aiming for exponential growth through smarter, data-centric decision-making in healthcare. The organization fosters a deeply interconnected team environment where members rely on one another to deliver results. Core values emphasize being relentlessly curious, resilient, nimble, and adventurous, supported by virtues such as collaboration, innovation, empowerment, and continuous learning. The central mantra, 'We Care,' reflects a compassionate and hopeful approach to their work.

• Driven by purpose and focused on exponential growth.
• Utilizes data-driven methods for healthcare decisions.
• Team members are deeply interconnected and mutually reliant.
• Values include being Relentlessly Curious, Resilient & Nimble, and Fearlessly Adventurous.
• Operates on virtues like Deciding, Doing, Collaborating, Innovating, Empowering, Adapting, and Learning.
• Guided by the 'We Care' mantra, emphasizing compassion and hope.

How to apply

Documents to submit:

• CV
• Supporting information