Senior IVD/CDx Program Lead

SOPHiA GENETICS; Cambridge; Hybride; GBP 127 000 - 172 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Free coffee & snacks

Rest & Entertainment space

Relocation support

Free parking

Résumé du poste

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end IVD development programs, including CTA, tumour profiling, CDx, and SaMD. The role requires deep regulatory and cross-functional leadership across development, verification, validation, and regulatory submission.

You will coordinate with Biopharma partners and internal teams to align milestones with drug development timelines, ensuring timely deliverables and robust governance across the program lifecycle.

Qualifications

• 8+ years in diagnostic product development or program ownership across IVD/CDx/clinical assays.
• 3+ years in cross-functional program leadership.

Responsabilités

• Define design and development strategy for IVD/CDx/SaMD programs and align with regulatory milestones.
• Build biopharma partnerships and manage joint development plans with Biopharma Business and Legal.
• Lead governance processes and ensure timely, informed decision-making.
• Coordinate Bioinformatics, verification/validation, regulatory, QA, manufacturing, and product teams.
• Deliver programs from requirements to regulatory submission and commercial launch.

Connaissances

End-to-end program leadership

Cross-functional leadership

Biopharma partner management

Regulatory strategy knowledge

Technical communication

Formation

B.S. degree or equivalent

PhD / MSc preferred

Description du poste

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end IVD development programs, including CTA, tumour profiling, CDx, and SaMD. The role requires deep regulatory and cross-functional leadership across development, verification, validation, and regulatory submission.

You will coordinate with Biopharma partners and internal teams to align milestones with drug development timelines, ensuring timely deliverables and robust governance across the program lifecycle.