IVD Development & Validation Lead — SOPHiA GENETICS
CHF 83'500 - 126'500
SOPHiA GENETICS · Rolle (VD)
- Ort
- Rolle
- Vertrag
- full-time
- Veröffentlicht
- vor 94 Tagen
LohnCHF 83'500 - 126'500
Rollenüberblick
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?
Bewerbungsprozess
- 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.
Unternehmen und Kontext
- 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
Weitere 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
Notizen und Originalinhalt
- 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
