Global CDx Program Leader (IVD) - Hybrid, Relocation

SOPHiA GENETICS; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health coverage (Helsana)

Meal vouchers

Free parking

Coffee and snacks

Social committee

Leadership exposure

Job summary

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end in vitro diagnostic programs, including CTAs and CDx, guiding cross-functional teams across development, validation, regulatory, and commercial workstreams. You will manage biopharma partnerships, governance, and complex timelines to deliver diagnostic solutions with impact for cancer and rare diseases.

The role requires extensive regulatory knowledge, collaboration with biopharma partners, and the ability to operate across global

Qualifications

• 8+ years in diagnostic product development or program ownership across IVD/CDx or clinical assays.
• Proven track record delivering IVD/CDx programs through FDA CE/CTA milestones.
• Deep knowledge of IVD and CDx development, validation, and regulatory strategy.
• Experience managing budgets, resources, risks, and multi-partner collaborations.
• Understanding of EU IVDR and FDA requirements preferred.
• Oncology experience and hands-on diagnostic platform background preferred.
• Bachelor’s degree required; advanced life sciences degree preferred.

Responsibilities

• Define design and development strategy for IVD, CTA, CDx, and SaMD programs aligned with milestones.
• Build biopharma partnerships and manage joint development plans with legal/commercial teams.
• Lead governance across portfolio reviews, design reviews, and steering committees.
• Integrate cross-disciplinary teams around a coherent program plan and milestones.
• Deliver programs from requirements to regulatory submission and commercialization.

Skills

Cross-functional leadership

Regulatory strategy

Biopharma partnerships

Budget & resource planning

Technical communication

Education

B.S. degree or equivalent

PhD / MSc preferred

Job description

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end in vitro diagnostic programs, including CTAs and CDx, guiding cross-functional teams across development, validation, regulatory, and commercial workstreams. You will manage biopharma partnerships, governance, and complex timelines to deliver diagnostic solutions with impact for cancer and rare diseases.

The role requires extensive regulatory knowledge, collaboration with biopharma partners, and the ability to operate across global