Senior Clinical Affairs Manager

SOPHiA GENETICS; Rolle; Hybrid; CHF 140.000 - 210.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Clinical affairs

Clinical operations

IVD experience

Molecular diagnostics

Stakeholder management

Regulatory collaboration

Study design critique

Jobbeschreibung

Do you bring a strong background in clinical affairs, clinical science, or clinical operations within IVD or molecular diagnostics?

Have you designed clinical performance studies and shaped clinical evidence strategy in an IVDR, CE-IVD, or companion diagnostics environment?

If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS team as a Senior Clinical Affairs Manager and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.

Enjoy the flexibility of a hybrid work schedule allowing 2 days PW home working, collaborating closely with colleagues in our Rolle, Switzerland corporate office.

Our Mission

We believe there is a smarter, more data-driven way to make decisions in healthcare and our cloud-native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. You will have direct input to our mission to democratize data-driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.

Your Mission

As Clinical Affairs Lead / Senior Clinical Affairs Manager, you will own the clinical performance strategy for validation work, partnering closely with internal stakeholders and external partners to design and deliver clinical performance studies in an IVD and molecular diagnostics context.

This is an individual contributor role with significant seniority and visibility. You will work cross-functionally with Regulatory Affairs, Clinical Operations, CROs, consultants, notified bodies, and biopharma partners, bringing the clinical and scientific expertise needed to shape study design, clinical risk evaluation, and clinical evidence requirements.

The value you add

• 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 closely with Regulatory Affairs on technical files, notified body interactions, and clinical evidence questions.
• Govern CRO activity day to day, reviewing outputs with a critical eye and holding external partners accountable for delivery.
• Contribute to the development of a strong validation function, working alongside analytical performance and clinical operations colleagues.

Requirements

• Significant experience in clinical affairs, clinical operations, clinical science, or a closely related discipline within IVD or molecular diagnostics.
• Strong exposure to IVD and CE-IVD environments; NGS experience is ideal, with molecular diagnostics experience as the minimum target background.
• Experience designing or contributing to clinical performance studies, including protocols, clinical evidence strategy, and study reporting.
• Experience managing CROs or strategic external partners, including reviewing outputs and driving accountability.
• Experience working closely 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.
• Experience with companion diagnostics, biopharma partnerships, NGS-based diagnostics, or IVDR clinical performance documentation and submissions would be valuable.
• A clinical or scientific background that enables you to critically assess study design, risk, and evidence requirements.

Benefits

• Sickness and Accident coverage through Helsana
• Meal Vouchers at 90CHF PM with our partner cafeteria
• A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks
• Free parking in an easy to access location
• A strong social committee whose purpose is to make SOPHiA GENETICs both enjoyable as well as rewarding
• As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally

Our DNA

Like the strands of DNA itself, SOPHiA GENETICS and the team are deeply interconnected and reliant on each other to deliver. There are common threads across the team. Things that bind us together. Those things are Relentless Curious; Resilient & Nimble and Fearlessly Adventurous.

Our Virtues

At SOPHiA GENETICS we established our 7 Virtues to clarify how our principles show up each day through action. We Decide; We Do; We Collaborate; We Innovate; We Empower; We Adapt and We Learn. At the centre of our Virtues is our Mantra, We Care, which provides a constant reminder of the compassionate, benevolent, and hopeful nature of our mission and how it should be threaded through each of our Virtues and everything we do.

Starting Date: ASAP

Location: Rolle, CH

Contract: Permanent