Hybrid Senior Clinical Affairs Lead, IVD & CDx Strategy

SOPHiA GENETICS; Rolle; Hybrid; CHF 140,000 - 210,000; Full time

Benefits offered by this job

Sickness and Accident coverage through

Meal vouchers CHF 90 per month

Free parking

Coffee and fruit/snacks

Social and leadership exposure

HQ access and executive interaction

Job summary

SOPHiA GENETICS is seeking a Senior Clinical Affairs Manager to own the clinical performance strategy for validation work in an IVD/molecular diagnostics context. You will partner closely with Regulatory Affairs, Clinical Operations, CROs, and external partners to design and deliver robust clinical studies with strong evidence.

This is an individual contributor role with high visibility. You will collaborate across regulatory and biopharma partners, shaping clinical risk evaluation and evidence

Qualifications

• Significant experience in clinical affairs, clinical operations, clinical science, or related discipline within IVD or molecular diagnostics.
• Experience designing or contributing to clinical performance studies, including protocols, clinical evidence strategy, and study reporting.
• Experience managing CROs or external partners, including reviewing outputs and driving accountability.
• Experience working with regulatory teams on technical files, notified body interactions, or clinical evidence requirements.
• Senior stakeholder presence, with the ability to engage confidently with CROs, consultants, regulatory partners, notified bodies, and biopharma partners.
• Clinical or scientific background enabling critical assessment of study design, risk, and evidence requirements.

Responsibilities

• Design and deliver clinical performance study strategy, protocols, and reports for IVDR and CDx programs.
• Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design.
• Partner with Regulatory Affairs on technical files, notified body interactions, and clinical evidence questions.
• Govern CRO activity day to day, reviewing outputs and ensuring accountability.
• Contribute to development of a strong validation function alongside analytical performance and clinical operations colleagues.

Skills

Clinical affairs

Clinical operations

IVD experience

Molecular diagnostics

Stakeholder management

Regulatory collaboration

Study design critique

Job description

SOPHiA GENETICS is seeking a Senior Clinical Affairs Manager to own the clinical performance strategy for validation work in an IVD/molecular diagnostics context. You will partner closely with Regulatory Affairs, Clinical Operations, CROs, and external partners to design and deliver robust clinical studies with strong evidence.

This is an individual contributor role with high visibility. You will collaborate across regulatory and biopharma partners, shaping clinical risk evaluation and evidence