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
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
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
