IVD Development & Validation Lead

SOPHiA GENETICS; Rolle; Hybrid; CHF 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Sickness and Accident coverage

Meal Vouchers

Engaging work environment

Free parking

Direct interaction with senior leadership

Social committee & leadership exposure

Zusammenfassung

A cutting-edge biotechnology company in Rolle, CH seeks an IVD Development & Validation Lead. This role involves owning validation programs for NGS-based IVD and CDx products, designing fit-for-purpose studies, and leading cross-functional teams. The candidate should have experience in developing IVD products and a strong understanding of regulatory pathways. This position offers a hybrid working model, combining on-site collaboration with remote flexibility. Join us to make a positive impact on patients' lives.

Qualifikationen

• Hands-on experience developing and validating NGS-based IVDs.
• Strong understanding of IVD analytic and clinical validation methodology.
• Working knowledge of FDA IVD regulatory pathways and EU IVDR.
• Good working knowledge of statistics as applied to IVD V&V and defensible methods.
• Experience contributing to Design History File and design controls.

Aufgaben

• Own validation programs for NGS-based IVD and CDx products.
• Design and execute validation studies with relevant methodologies.
• Produce documentation ready for regulatory reviews.
• Produce DHF-ready documentation with clear, review-friendly reporting.
• Build reusable validation frameworks, templates, and SOPs for scalable programs.
• Lead or mentor assay development and validation scientists in the team.

Kenntnisse

NGS-based IVD development

Statistical analysis

Technical writing

Clinical validation methodology

Regulatory pathways knowledge

Jobbeschreibung

IVD Development & Validation Lead

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.

Hybrid opportunity: 3 days onsite at our corporate office in Rolle, CH.

Our Mission

We believe there is a smarter, more data‑driven way to make decisions in healthcare and our cloud‑native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. 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. We work primarily in oncology and inherited disorders, where integrating genomic and phenotypic data is critical for clinical decision‑making, research, and drug development.

Our data‑sharing methodology connects researchers and clinicians globally, supporting a community‑driven approach to precision medicine. Our mission is to democratize data‑driven medicine and ensure that every patient has access to the best possible diagnosis.

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.

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.
• 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.

Technical project leadership (for more senior candidates)

• 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.

Diagnostics development processes

• 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

Essential

• Hands‑on experience developing and validating NGS‑based IVDs in a clinical diagnostic or CDx context.
• A thorough understanding of IVD analytic 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.

A strong plus

• 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 the critical outcomes.
• Experience building validation infrastructure in a scaling environment: SOPs, templates, frameworks.
• Prior experience leading or mentoring assay development and validation scientists.

Benefits

You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.

Business recognition and accolades include:

• World's most innovative companies (Top 10)
• World's smartest companies (Top 50)
• 100 Best Places to Work in Boston
• Top 10 European Tech Startup
• Top 10 European biotechs startup to watch
• Top 25 East‑Coast Biotech to watch

Our benefits package is comprehensive, but varies internationally in‑line with local standards and laws. You can discuss a full breakdown with us, but as a brief overview:

• 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

Details

Starting Date: ASAP

Location: Rolle, CH

Contract: Permanent