Senior IVD/CDx Program Lead

Phia LLC; Lavamünd; Vor Ort; EUR 190.000 - 243.000; Vollzeit

Benefits dieser Stelle

Helsana health coverage

Meal vouchers 90CHF PM

Free parking

Hybrid work environment

Relocation assistance

Access to senior leadership

Zusammenfassung

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end IVD development programs, including CTA, tumor profiling and companion diagnostics, in collaboration with biopharma partners. You will coordinate cross-functional teams across development, verification and validation, clinical, regulatory and commercial workstreams.

The role demands deep IVD/CDx knowledge, strong program leadership, and the ability to manage complex external partnerships in a matrix environment.

Qualifikationen

• 8+ years in diagnostic product development or program ownership across IVD/CDx.
• Track record delivering programs through regulatory milestones (FDA CE).
• Deep knowledge of IVD/CDx development, validation, and regulatory strategy.
• Experience budgeting, resourcing, risks, and multi-partner collaborations.

Aufgaben

• Lead end-to-end strategic and operational management of IVD development programs.
• Partner with biopharma teams, align cross-functional workstreams and milestones.
• Ensure regulatory submissions are timely and aligned with drug development timelines.
• Drive governance through portfolio reviews and joint development teams.

Kenntnisse

Cross-functional leadership

Regulatory strategy

Biopharma partnerships

Technical communication

Ausbildung

BS in life sciences

PhD or MSc in molecular biology/genomics

Tools

Bioinformatics familiarity

Jobbeschreibung

SOPHiA GENETICS is seeking a Program Leader to drive end-to-end IVD development programs, including CTA, tumor profiling and companion diagnostics, in collaboration with biopharma partners. You will coordinate cross-functional teams across development, verification and validation, clinical, regulatory and commercial workstreams.

The role demands deep IVD/CDx knowledge, strong program leadership, and the ability to manage complex external partnerships in a matrix environment.