PAre 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? /ppIf this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Bioinformatic Product Development team as our bIVD Development Validation Lead /b, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide. /ppThis role is a hybrid opportunity, requiring 3 days onsite our corporate office in Rolle, CH. /ppbOur Mission /b /ppWe 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. /ppOur 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. /ppbYour Mission /b /ppSOPHiA 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. /ppThis 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 VV and the full regulatory evidence package. /ppWe 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. /ppbThe value you bring /b /ppValidation /pliOwn the design and execution of validation programs for NGS-based IVD and CDx products, covering analytical performance, clinical performance, usability, and stability. /liliDesign 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. /liliHandle the statistical aspects of VV 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. /liliProduce DHF-ready documentation, written clearly enough to be reviewed without extensive back-and-forth. /liliBuild reusable validation frameworks, templates, and SOPs that can be applied consistently across programs /lipTechnical project leadership (for more senior candidates) /pliBe 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. /liliConnect the development, validation, and regulatory sub-teams, to ensure efficient project delivery and effective project risk mitigation. /liliDefine the regulatory evidence strategy in collaboration with the Regulatory Lead: what is required, what is sufficient, what is not needed. /lipDiagnostics development processes /pliDesign the processes and standards that allow a growing diagnostics portfolio to be delivered consistently and efficiently across programs. /liliWork closely with NGS scientists, bioinformaticians, regulatory, quality, and product colleagues across a highly cross-functional environment. /liliContribute to developing IVD capability across the organization and mentoring junior scientists where relevant. /lipbRequirements /b /ppEssential: /pliHands-on experience developing and validating NGS-based IVDs in a clinical diagnostic or CDx context. /liliA thorough understanding of IVD analytical 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. /liliWorking 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. /liliGood working knowledge of statistics as applied to IVD VV: familiar with the standard approaches across the main study types, and able to establish pragmatic, defensible methods. Deeper statistical expertise is a plus. /liliExperience working within design controls and contributing to a Design History File. /liliClear, precise technical writing. Protocols and reports that are complete and reviewable without the need for extensive edits. /lipA strong plus: /pliExperience in oncology diagnostics. /liliExperience on CDx programs developed in partnership with pharma, including CTA and IUO studies. /liliA track record of delivering VV programs on tight timelines without compromising on what matters. /liliExperience building validation infrastructure in a scaling environment: SOPs, templates, frameworks. /liliPrior experience leading or mentoring assay development and validation scientists /lipbBenefits /b /ppYou will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth. /ppBusiness recognition and accolades include: /pliWorld's most innovative companies (Top 10) /liliWorld's smartest companies (Top 50) /lili100 Best Places to Work in Boston /liliTop 10 European Tech Startup /liliTop 10 European biotechs startup to watch /liliTop 25 East-Coast Biotech to watch /lipOur 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: /pliSickness and Accident coverage through Helsana /liliMeal Vouchers at 90CHF PM with our partner cafeteria /liliA fun and engaging work environment, with Rest Entertainment space, full stocked free coffee machine and free fruit/snacks /liliFree parking in an easy to access location /liliA strong social committee whose purpose is to make SOPHiA GENETICs both enjoyable as well as rewarding /liliAs our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally /lipbOur DNA /b /ppLike the strands of DNA itself, SOPHiA GENETICS and the team are deeply interconnected and reliant on each other to deliver. There are common threads across the team. Things that bind us together. Those things are Relentless Curious; Resilient Nimble and Fearlessly Adventurous /ppbOur Virtues /b /ppAt SOPHiA GENETICS we established our 7 Virtues to clarify how our principles show up each day through action. We Decide; We Do; We Collaborate; We Innovate; We Empower; We Adapt and We Learn. /ppAt the centre of our Virtues is our Mantra, We Care, which provides a constant reminder of the compassionate, benevolent, and hopeful nature of our mission and how it should be threaded through each of our Virtues and everything we do. Learn more about our DNA and Virtues on our Careers portal /ppbThe Process /b /ppWe use the power of AI to help our partners make decisions. If you’re utilising AI in your search and application process, why not use some of these prompts, or read our AI guide. /pp‘What impact can I expect to have on the world by working at SOPHiA GENETICS?’ /pp‘I have an interview with SOPHiA GENETICS. What should I know before I meet with them?’ /pp‘I am a *job title* - What can SOPHiA GENETICS offer my career?’ /ppApply now with your CV and any supporting information. /ppSuitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader alongside key colleagues and stakeholders from across the business. If you need additional support for accessibility, please contact our TA team for assistance. /ppWe appreciate the value external partners can bring, but we operate a direct-hiring model and we are not looking to utilize agency support at this time. All hiring is controlled by Talent Acquisition, potential partners should liaise through TA and not our hiring teams please. /ppStarting Date: ASAP /ppLocation: Rolle, CH /ppContract: Permanent /p