Program Leader - Diagnostics Solutions

About Us

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.

The Role

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.

Requirements

We know that every background is different, but to be best set for success we see you bringing:

• 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 complex external biopharma partnerships in a matrixed, multi-partner environment.
• The ability to move between high-level business strategy and tactical daily program operations, supported by strong technical communication, influencing, 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.
• Oncology therapeutic area experience and a hands-on technical background in one or more diagnostic platforms are preferred.
• A B.S. degree or equivalent is required; a PhD, MSc, or equivalent degree in molecular biology, biochemistry, analytical chemistry, genomics, pathology, or a related life sciences discipline is preferred.

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 biotech 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