Principal Program Manager (IVD/CDx)

• 04 September 2026
• 100%
• Indefinite duration
• Rolle

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

If this fits you and you are purpose-driven, join the SOPHiA GENETICS Diagnostics Solutions team as a Program Manager and allow us to have a positive impact on outcomes for cancer and rare disease patients worldwide.

Benefit from the flexibility of a hybrid schedule allowing 2 days per week of teleworking, collaborating closely with colleagues at our headquarters in Rolle, CH. International relocation may be supported for this opportunity.

Our Mission ###

We believe there is a smarter, more data-driven way to make healthcare decisions, and our cloud-native, AI-powered SOPHiA DDM platform realizes this vision every day. You will have a direct influence on our mission to democratize data-driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.

Your Mission ###

As a Program Manager, you will be responsible for the end-to-end strategic and operational leadership of one or more in vitro diagnostic development programs, including clinical trials, tumor profiling tests, companion diagnostics, and software as a medical device. You will ensure that programs are co-developed, validated, and submitted on time and in accordance with the drug development timeline of each biopharmaceutical partner. This role requires deep knowledge of IVD and CDx development, strong biopharmaceutical client management skills, as well as the ability to orchestrate cross-functional teams across development, verification and validation, clinical, regulatory, and commercial aspects.

The Value You Bring ###

• Define and assume the design and development strategy for IVD, CTA, tumor profiling, CDx and/or SaMD programs, aligning analytical and clinical validations as well as regulatory timelines with biopharmaceutical drug development milestones, including IND, Phase I/II/III, BLA, NDA, and MAA.
• Build trusted biopharmaceutical 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 the Biopharma Business and Legal teams.
• Lead internal and joint governance - including portfolio reviews, commercial milestones, design reviews, joint steering committees, and joint development teams - to foster aligned and 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.

Requirements

We know that every journey is different, but to maximize your chances of success, we expect from you:

• More than 8 years of experience in diagnostic product development or program/project management in the fields of IVD, CDx, or clinical laboratory testing, including at least 3 years in leading cross-functional projects or programs.
• A demonstrated track record of delivering an IVD or CDx program through FDA approval or CE marking, or a CTA via 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 in budget management, resource planning, technical and regulatory risk management, as well as complex external biopharmaceutical partnerships in a multi-partner matrix environment.
• The ability to navigate between high-level commercial strategy and daily tactical program operations, supported by strong technical communication, influence, negotiation, and conflict resolution skills.
• A solid understanding of drug-diagnostic co-development and the regulatory interdependencies between CDx and drug approval; familiarity with EU IVDR and FDA requirements is preferred.
• Experience in the oncology therapeutic area and practical technical background on one or more diagnostic platforms are preferred.
• A bachelor's degree or equivalent is required; a PhD, master's, or equivalent degree in molecular biology, biochemistry, analytical chemistry, genomics, pathology, or a related life sciences discipline is preferred.

Benefits

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