Senior Clinical Affairs Lead IVD & CDx Strategy

Phia LLC; Indiana (PA); Hybrid; USD 161,090 - 223,048; Full time

Benefits offered by this job

Hybrid work model

Exposure to senior leadership

Job summary

SOPHiA GENETICS is seeking a Senior Clinical Affairs Manager to lead clinical performance strategy in IVDR/CDx contexts. You will partner with Regulatory Affairs, CROs, and external partners to shape study design and evidence requirements.

This individual contributor role combines senior-level influence with hands-on clinical science, driving validation work and clinical risk evaluation within a hybrid Switzerland-based setting.

Qualifications

• Significant experience in clinical affairs within IVD or molecular diagnostics.
• Strong exposure to IVD/CE-IVD environments; NGS experience is ideal.
• Experience designing or contributing to clinical performance studies.

Responsibilities

• Design and deliver clinical performance study strategy, protocols, and reports.
• Partner with Regulatory Affairs and CROs to define evidence strategy.
• Own validation activities, clinical risk evaluation, and study design.
• Collaborate with biopharma partners and notified bodies on submissions.
• Provide expert clinical input for technical files and regulatory questions.

Skills

Clinical affairs

Clinical operations

Clinical science

Molecular diagnostics

IVD

Job description

SOPHiA GENETICS is seeking a Senior Clinical Affairs Manager to lead clinical performance strategy in IVDR/CDx contexts. You will partner with Regulatory Affairs, CROs, and external partners to shape study design and evidence requirements.

This individual contributor role combines senior-level influence with hands-on clinical science, driving validation work and clinical risk evaluation within a hybrid Switzerland-based setting.