IVD/CDx Program Leader — Oncology Diagnostics

SOPHiA GENETICS; Lavamünd; Hybrid; EUR 191.000 - 255.000; Vollzeit

Benefits dieser Stelle

Hybrid work arrangement

International relocation assistance

Competitive compensation

Zusammenfassung

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end IVD development programs, including CTA, tumor profiling, and CDx. You will coordinate cross-functional teams across development, regulatory, clinical, and commercial workstreams to align with biopharma partner milestones.

You will manage complex external partnerships, ensure timely regulatory submissions, and oversee strategy from discovery through launch, with international relocation support where applicable.

Qualifikationen

• 8+ years of experience in diagnostic product development or program ownership.
• Proven track record delivering IVD/CDx programs through regulatory approval or pivotal trials.
• Deep knowledge of IVD/CDx development, validation, and regulatory strategy.

Aufgaben

• Lead end-to-end IVD development programs (CTA, tumor profiling, CDx, SaMD).
• Co-develop, validate, and submit programs on time aligning with partner timelines.
• Coordinate cross-functional teams across development, regulatory, clinical, and commercial streams.

Kenntnisse

Cross-functional leadership

Program leadership

Diagnostic product development

Regulatory strategy

Regulatory affairs

Strategic communication

Ausbildung

PhD / MSc in life sciences

Bachelor's degree required

Jobbeschreibung

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end IVD development programs, including CTA, tumor profiling, and CDx. You will coordinate cross-functional teams across development, regulatory, clinical, and commercial workstreams to align with biopharma partner milestones.

You will manage complex external partnerships, ensure timely regulatory submissions, and oversee strategy from discovery through launch, with international relocation support where applicable.