Senior IVD/CDx Programs Leader

SOPHiA GENETICS; Lavamünd; Hybrid; EUR 149.000 - 202.000; Vollzeit

Benefits dieser Stelle

Hybrid work schedule

Relocation support

Exposure to senior leadership

Zusammenfassung

SOPHiA GENETICS Diagnostics Solutions team seeks a Program Leader to drive end-to-end IVD development programs, including CTAs, tumor profiling tests, and Companion Diagnostics, coordinating cross-functional teams and biopharma partners to meet regulatory and commercial milestones.

You will ensure programs are co-developed, validated, and submitted on time, with expertise in regulatory interactions and global strategy.

Qualifikationen

• 8+ years of diagnostic product development or program ownership across IVD/CDx.
• Proven track record delivering program through FDA/CE or pivotal trials.
• Experience coordinating cross-functional teams across development, regulatory and commercial workstreams.

Aufgaben

• Define and own design and development strategy for IVD, CDx, and SaMD programs.
• Lead biopharma partnerships as primary project contact with joint development plans.
• Oversee governance: portfolio reviews, design reviews, and steering committees.
• Coordinate cross-functional teams across development, regulatory, and commercial workstreams.
• Deliver programs from requirements through regulatory submission and launch.

Kenntnisse

IVD development

CDx development

Cross-functional leadership

Regulatory strategy

Biopharma partnerships

Budget management

Regulatory submissions

Clinical trial programs

Ausbildung

B.S. degree in life sciences

PhD / MSc preferred

Jobbeschreibung

SOPHiA GENETICS Diagnostics Solutions team seeks a Program Leader to drive end-to-end IVD development programs, including CTAs, tumor profiling tests, and Companion Diagnostics, coordinating cross-functional teams and biopharma partners to meet regulatory and commercial milestones.

You will ensure programs are co-developed, validated, and submitted on time, with expertise in regulatory interactions and global strategy.