Senior Program Leader; IVD​/CDx

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.

Enjoy the flexibility of a hybrid work schedule allowing 2 days PW home working, collaborating closely with colleagues in our Rolle, CH corporate office. International relocation can be supported for this opportunity.

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.

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 work streams.

• 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.

• 8+ years of experience in diagnostic product development or program/project ownership across IVD, CDx, or clinical laboratory assays, including at least 3 years in cross-functional project or program leadership.
• A demonstrated track record of delivering an IVD or CDx program through FDA approval or CE marking, or a CTA through a pivotal clinical trial.
• Deep knowledge of IVD and CDx development, including assay and bioinformatics development, analytical and clinical validation, design controls, regulatory interactions, and global regulatory strategy.
• Experience managing budgets, resource planning, technical and regulatory risks, and…