IVD Development & Validation Lead

SOPHiA GENETICS seeks an IVD Development & Validation Lead in Rolle, CH, to design and execute validation programs for NGS-based diagnostic products within a hybrid work model.

This position sits within the Bioinformatic Product Development team, supporting a cross-functional organization that is expanding its companion diagnostic (CDx) and companion test (CTA) portfolio. The role is critical for scaling IVD development capabilities and ensuring rigorous validation standards that ultimately improve outcomes for patients with cancer and rare diseases globally.

Responsibilities

• Lead the end-to-end technical success of CDx and CTA development programs.
• Design and implement validation strategies for NGS-based IVD products, ensuring fit-for-purpose methodology and statistical rigor.
• Create reusable validation frameworks, templates, and standard operating procedures (SOPs).
• Produce clear, DHF-ready documentation that minimizes review cycles.
• Collaborate with regulatory leads to define evidence strategies and connect development, validation, and regulatory sub-teams.
• Establish processes and standards to ensure consistent delivery across a growing diagnostics portfolio.
• Mentor junior scientists and help build IVD expertise throughout the organization.

Requirements

• Proven experience in developing and validating NGS-based IVDs within clinical diagnostic or CDx settings.
• Deep understanding of analytical and clinical validation methodologies for IVDs.
• Working knowledge of FDA IVD regulatory pathways (510(k), De Novo, PMA, CTA/IUO) and/or EU IVDR.
• Strong statistical skills applied to IVD verification and validation studies.
• Experience working within design controls and contributing to Design History Files (DHF).
• Excellent technical writing abilities with a focus on clarity and precision.

Nice to have

• Background in oncology diagnostics.
• Experience with CDx programs developed in partnership with pharmaceutical companies, including CTA and IUO studies.
• Track record of delivering validation programs under tight deadlines.
• Experience building validation infrastructure in a scaling environment.
• Prior leadership or mentoring experience in assay development and validation.

What the company offers

• Sickness and accident coverage provided through Helsana.
• Meal vouchers valued at 90 CHF per month via the partner cafeteria.
• Access to rest and entertainment spaces, including a fully stocked free coffee machine and complimentary fruit and snacks.
• Free parking in a conveniently located facility.
• Active social committee fostering team connection.
• Direct exposure to senior leadership and the executive team.

About the company

SOPHiA GENETICS is driven by a purpose-led mission to achieve exponential growth while maintaining a deeply interconnected team culture. The organization emphasizes core values such as being relentlessly curious, resilient, nimble, and fearlessly adventurous. Its seven virtues—deciding, doing, collaborating, innovating, empowering, adapting, and learning—are anchored by the central mantra 'We Care,' reflecting a compassionate and hopeful approach to its mission.

• Driven by purpose and focused on exponential growth.
• Deeply interconnected team reliant on mutual support.
• Core values include Relentless Curious, Resilient & Nimble, and Fearlessly Adventurous.
• Seven Virtues: We Decide, We Do, We Collaborate, We Innovate, We Empower, We Adapt, and We Learn.
• Central mantra 'We Care' emphasizes compassion and hope.

How to apply

Documents to submit:

• CV