IVD Development & Validation Lead — SOPHiA GENETICS
- Location
- Rolle
- Contract
- full-time
- Posted
- 113 days ago
Role overview
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.
- 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?
Application process
- 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.
Company and context
- This role sits within a cross-functional organization, working closely with colleagues across bioinformatics, NGS assay development, regulatory, and clinical operations.
- Depending on your background, you will own the validation program for one or more CDx/CTA projects or take broader technical ownership across the full development lifecycle, from assay and bioinformatics pipeline development through V&V and the full regulatory evidence package.
- We work with urgency and purpose to meet the demands of patients and our pharma partners.
- This means knowing what a study needs to demonstrate, designing it accordingly, and not adding work that does not contribute to that goal.
- It also means building processes and standards that hold up as the portfolio grows. The value you bring Validation
- 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.
- 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
Additional details
- This role is a hybrid opportunity, requiring 3 days onsite our corporate office in Rolle, CH.
- Our mission is to democratize data-driven medicine and ensure that every patient has access to the best possible diagnosis.
- It also means building processes and standards that hold up as the portfolio grows. The value you bring
- Define the regulatory evidence strategy in collaboration with the Regulatory Lead: what is required, what is sufficient, what is not needed. Diagnostics development processes
Notes and original content
- Our Mission
- Your Mission
- It also means building processes and standards that hold up as the portfolio grows.
- The value you bring
- Validation
- Define the regulatory evidence strategy in collaboration with the Regulatory Lead: what is required, what is sufficient, what is not needed.
- Diagnostics development processes
Questions about this listing
What salary does SOPHiA GENETICS offer for this role?
SOPHiA GENETICS lists CHF 83'500 - 126'500 gross per year for this position in Rolle. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does SOPHiA GENETICS offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with SOPHiA GENETICS during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Vaud?
EU/EFTA residents living in the border zone of the country adjoining Canton Vaud can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Vaud's cantonal migration office or with HR during the application.
How do I apply for this position at SOPHiA GENETICS?
Use the "Apply now" button on this page — it links directly to SOPHiA GENETICS's original listing at apply.workable.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
