Senior Program Leader (IVD/CDx) (Relocation to Switzerland)

Do you bring deep experience in IVD or companion diagnostic product development and a track record of leading complex programs through regulatory approval or pivotal clinical trials? Can you align cross-functional teams and biopharma partners around the scientific, regulatory, operational, and commercial milestones needed to deliver diagnostic solutions?

If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Diagnostics Solutions team as a Program Leader and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.

This role is attached to our Corporate HQ in Switzerland. For any individuals not based in Switzerland, this would require international relocation but this can be support for suitably qualified individuals. This role cannot be done remotely from outside of Switzerland.

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. You will have direct input to our mission to democratize data-driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.

Your Mission

As Program Leader, you will be accountable for the end-to-end strategic and operational leadership of one or more in vitro diagnostic development programs, including Clinical Trial Assays, tumor profiling tests, Companion Diagnostics, and software as a medical device. You will ensure programs are co-developed, validated, and submitted on time and in alignment with each biopharma partner's drug development timeline. This role requires deep knowledge of IVD and CDx development, strong biopharma customer management skills, and the ability to orchestrate cross-functional teams across development, verification and validation, clinical, regulatory, and commercial workstreams.

The value you add

• Define and own the design and development strategy for IVD, CTA, tumor profiling, CDx, and/or SaMD programs, aligning analytical and clinical validation and regulatory timelines with biopharma drug development milestones, including IND, Phase I/II/III, BLA, NDA, and MAA.
• Build trusted biopharma partnerships as the primary project contact, maintaining transparency on status, risks, decisions, co-development agreements, technical feasibility scopes, and joint development plans in collaboration with Biopharma Business and Legal.
• Lead internal and joint governance-including portfolio reviews, business stage gates, design reviews, Joint Steering Committees, and Joint Development Teams-to drive aligned, timely decision-making.
• Integrate Bioinformatics and Assay Development, Verification and Validation, Clinical Operations, Regulatory Affairs, Quality Assurance, Manufacturing, Product Management, and Biopharma teams around a coherent program strategy, milestones, resources, and shared accountability.
• Deliver diagnostic programs from requirements definition through product development, verification and validation, regulatory submission, and commercial launch while managing timelines, budgets, risks, resources, and contingency plans.