Senior IVD/CDx Program Leader - Hybrid, Global Impact

Phia LLC; Lavamünd; Hybrid; EUR 128.000 - 170.000; Vollzeit

Benefits dieser Stelle

Helsana health coverage

Meal vouchers CHF 90 PM

Free parking

Hybrid work model

Zusammenfassung

SOPHiA GENETICS is seeking a Program Leader to oversee end-to-end development of in vitro diagnostic programs, including CTA, tumor profiling, and companion diagnostics. You will coordinate cross-functional teams across development, QA, regulatory, and commercial workstreams with biopharma partners to deliver on regulatory timelines.

The role requires deep IVD/CDx expertise, strong leadership, and a track record of successful regulatory submissions.

Qualifikationen

• 8+ years in diagnostic product development or program ownership across IVD/CDx or clinical assays.
• Proven track record delivering IVD/CDx programs through FDA CE/CTA milestones.
• Deep knowledge of IVD/CDx development, validation, and regulatory strategy.

Aufgaben

• Define and own design/development strategy for IVD, CDx and SaMD programs aligned with regulatory timelines.
• Lead co-development and governance with biopharma partners and internal teams.
• Drive program milestones, risk management, budgeting, and cross-functional collaboration.

Kenntnisse

Cross-functional leadership

Regulatory strategy

Biopharma partnerships

Program leadership

Biology / life sciences

Ausbildung

Bachelor- level degree in life sciences

PhD / MSc preferred

Jobbeschreibung

SOPHiA GENETICS is seeking a Program Leader to oversee end-to-end development of in vitro diagnostic programs, including CTA, tumor profiling, and companion diagnostics. You will coordinate cross-functional teams across development, QA, regulatory, and commercial workstreams with biopharma partners to deliver on regulatory timelines.

The role requires deep IVD/CDx expertise, strong leadership, and a track record of successful regulatory submissions.