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IVD & CDx Validation Lead

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SOPHiA GENETICS

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Location:
Switzerland , Rolle

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Are you an experienced IVD professional specializing in NGS-based IVD and CDx products? Ready to take on impactful new projects at the forefront of precision medicine? If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Bioinformatic Product Development team as our IVD Development & Validation Lead, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide. This is a hybrid (3 Days PW) opportunity connected to our corporate offices in Switzerland (Rolle). International relocation can be supported and this advert is for candidates actively looking to relocate to Switzerland. This role cannot be performed remotely from another country.

Job Responsibility:

  • Own the design and execution of validation programs for NGS-based IVD and CDx products, covering analytical performance, clinical performance, usability, and stability
  • Design studies that are fit for purpose: the right methodology, acceptance criteria, and statistical approaches based on what needs to be demonstrated and the applicable regulatory context, drawing on relevant guidance (CLSI, professional standards, etc) and your own experience
  • Handle the statistical aspects of V&V studies across the full range of study types - you know the standard approaches, when to apply them, and how to establish defensible methods. You do not need to be a dedicated biostatistician, but you need a solid command of the standard approaches
  • Produce DHF-ready documentation, written clearly enough to be reviewed without extensive back-and-forth
  • Build reusable validation frameworks, templates, and SOPs that can be applied consistently across programs
  • Be accountable for the technical success of CDx/CTA development programs end-to-end, from assay and bioinformatics pipeline development through verification, validation, and submission-ready regulatory evidence
  • Connect the development, validation, and regulatory sub-teams, to ensure efficient project delivery and effective project risk mitigation
  • Define the regulatory evidence strategy in collaboration with the Regulatory Lead: what is required, what is sufficient, what is not needed
  • Design the processes and standards that allow a growing diagnostics portfolio to be delivered consistently and efficiently across programs
  • Work closely with NGS scientists, bioinformaticians, regulatory, quality, and product colleagues across a highly cross-functional environment
  • Contribute to developing IVD capability across the organization and mentoring junior scientists where relevant

Requirements:

  • Hands-on experience developing and validating NGS-based IVDs in a clinical diagnostic or CDx context
  • A thorough understanding of IVD analytical and clinical validation methodology: how to design studies that are fit for purpose, what guidance frameworks apply and when, and how to make and defend scope decisions
  • Working knowledge of FDA IVD regulatory pathways (510(k), De Novo, PMA, CTA/IUO) and/or EU IVDR, sufficient to design a validation program that holds up under regulatory review
  • Good working knowledge of statistics as applied to IVD V&V: familiar with the standard approaches across the main study types, and able to establish pragmatic, defensible methods. Deeper statistical expertise is a plus
  • Experience working within design controls and contributing to a Design History File
  • Clear, precise technical writing. Protocols and reports that are complete and reviewable without the need for extensive edits

Nice to have:

  • Experience in oncology diagnostics
  • Experience on CDx programs developed in partnership with pharma, including CTA and IUO studies
  • A track record of delivering V&V programs on tight timelines without compromising on what matters
  • Experience building validation infrastructure in a scaling environment: SOPs, templates, frameworks
  • Prior experience leading or mentoring assay development and validation scientists
What we offer:
  • 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

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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