IVD Development & Validation Lead

Role

Lead

Science & Research

Logistics

Rolle, Switzerland

Hybrid

60–100%

Requirements

5+ yrs exp

Master's

EU/EFTA permit

Skills

Technical writingNGS-based IVD developmentBioinformatics pipeline developmentIVD regulatory pathwaysStatistical analysis for V&VMentoringDesign History File documentationProject management softwareDiagnosticsCDx (Companion Diagnostics)Verification engineeringAnalytical method development

Description

Your Mission SOPHiA GENETICS has a strong NGS platform, established pharma partnerships, and a track record of delivering CE-IVD certified products. We are now scaling our CDx and CTA portfolio and investing in the IVD development and validation expertise to match that ambition, including under the more demanding requirements of IVDR and FDA.

Responsibilities

Own the design and execution of validation programs for NGS-based IVD and CDx products.
Design studies that are fit for purpose.
Handle the statistical aspects of V&V studies.
Produce DHF-ready documentation.
Build reusable validation frameworks, templates, and SOPs.
Be accountable for the technical success of CDx/CTA development programs.
Connect the development, validation, and regulatory sub-teams.
Define the regulatory evidence strategy.
Design the processes and standards for diagnostics development.
Contribute to developing IVD capability across the organization.

Requirements

Hands-on experience developing and validating NGS-based IVDs.
A thorough understanding of IVD analytical and clinical validation methodology.
Working knowledge of FDA IVD regulatory pathways and/or EU IVDR.
Good working knowledge of statistics as applied to IVD V&V.
Experience working within design controls and contributing to a Design History File.
Clear, precise technical writing.
Experience in oncology diagnostics is a strong plus.
Experience on CDx programs developed in partnership with pharma.
A track record of delivering V&V programs on tight timelines.
Experience building validation infrastructure in a scaling environment.

Benefits

Sickness and Accident coverage through Helsana.
Meal Vouchers at 90CHF PM with our partner cafeteria.
A fun and engaging work environment.
Free parking in an easy to access location.
Direct interaction and exposure to senior leadership.

Company

SOPHiA GENETICS

Biotechnology

SOPHiA GENETICS is the creator of SOPHiA DDM™, a cloud-based platform for analyzing complex multimodal data and generating insights that help healthcare institutions make faster, better informed decisions.