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SOPHiA GENETICS

Cloud-based AI platform for genomic analytics

Senior Clinical Operations Manager

Clinical Research OperationsUpdated on Nov 14
Full-timeRolle, SwitzerlandNo salary listed

About the Job

Requirements

  • Significant experience in clinical affairs, clinical operations, clinical science, or a closely related discipline within in vitro diagnostics or molecular diagnostics.
  • Strong exposure to in vitro diagnostics and CE-IVD environments; molecular diagnostics experience is the minimum target background.
  • Experience designing or contributing to clinical performance studies, including protocols, clinical evidence strategy, and study reporting.
  • Experience managing contract research organizations 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 and the ability to engage confidently with contract research organizations, consultants, regulatory partners, notified bodies, and biopharma partners.
  • A clinical or scientific background that enables critical assessment of study design, risk, and evidence requirements.

Responsibilities

  • Own the clinical performance strategy for validation work, partnering with internal stakeholders and external partners to design and deliver clinical performance studies in an in vitro diagnostics and molecular diagnostics context.
  • Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design.
  • Support the design of clinical performance study strategies.
  • Deliver clinical study protocols and reports for IVDR and companion diagnostics programs.
  • Partner with Regulatory Affairs on technical files, notified body interactions, and clinical evidence questions.
  • Govern contract research organization activity day to day, reviewing outputs critically and holding external partners accountable for delivery.
  • Contribute to the development of a strong validation function alongside analytical performance and clinical operations colleagues.

Desired Qualifications

  • Next-generation sequencing experience is ideal.
  • Experience with companion diagnostics, biopharma partnerships, next-generation sequencing-based diagnostics, or IVDR clinical performance documentation and submissions would be valuable.

About the Company

SOPHiA GENETICS

Cloud-based AI platform for genomic analytics

Sophia Genetics provides a cloud-based platform called SOPHiA DDM that uses AI and machine learning to analyze digital health data, especially genomic profiles, for healthcare providers, researchers, and pharma companies. It standardizes, computes, and analyzes multimodal data to support diagnosis, therapy selection, analysis, and drug development. Customers own their data and can share insights through the platform, contributing to collective intelligence. The platform is charged on a subscription or access basis, creating a global data-driven medicine ecosystem. The company differentiates itself by enabling data ownership for users, facilitating data sharing among institutions, and handling complex multimodal genomic data to drive better patient outcomes.

Company size
501-1,000
Company stage
IPO
Headquarters
Saint-Sulpice, Switzerland
Founded
2011

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