Senior IVD/CDx Program Lead - Hybrid, Relocation

SOPHiA GENETICS; Rolle; Hybrid; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Hybrid work schedule

International relocation support

Zusammenfassung

SOPHiA GENETICS is seeking a Program Leader for Diagnostics Solutions in Rolle, Switzerland. The hybrid role focuses on end-to-end IVD/CDx development programs, coordinating cross-functional teams through validation, regulatory submissions, and commercial launch.

You will collaborate with Biopharma partners, manage budgets, and drive alignment across development, regulatory, and clinical workstreams to meet IND/CE/MII timelines. International relocation is supported.

Qualifikationen

• 8+ years in diagnostic product development or program ownership across IVD/CDx or clinical assays.
• Track record delivering IVD/CDx programs through FDA approval or CE marking or pivotal trials.
• Deep knowledge of IVD/CDx development including validation, design controls, regulatory interactions, and global strategy.
• Experience managing budgets, resources, and multi-partner biopharma programs.
• Strong communication, negotiation and cross-functional leadership.
• Familiarity with EU IVDR and FDA requirements preferred.
• Oncology experience and hands-on diagnostics platform expertise preferred.
• BS required; PhD/MSc preferred.

Aufgaben

• Lead end-to-end strategic and operational leadership of one or more IVD/CDx development programs, including Clinical Trial Assays and companion diagnostics.
• Coordinate cross-functional teams across development, verification/validation, clinical, regulatory, quality, manufacturing and product management.
• Manage biopharma partnerships with clear governance, risk management, and on-time milestone delivery.
• Ensure alignment of validation, regulatory submissions, and drug development timelines with partner plans.
• Deliver programs from requirements to regulatory submission and commercial launch.

Kenntnisse

IVD development

CDx development

Cross-functional leadership

Regulatory strategy

Biopharma partner management

Technical communication

Problem solving

Ausbildung

B.S. degree or equivalent

Advanced degree (PhD/MSc) preferred

Jobbeschreibung

SOPHiA GENETICS is seeking a Program Leader for Diagnostics Solutions in Rolle, Switzerland. The hybrid role focuses on end-to-end IVD/CDx development programs, coordinating cross-functional teams through validation, regulatory submissions, and commercial launch.

You will collaborate with Biopharma partners, manage budgets, and drive alignment across development, regulatory, and clinical workstreams to meet IND/CE/MII timelines. International relocation is supported.