Senior Clinical Affairs manager

SOPHiA GENETICS; Rolle; Hybride; USD 161 090 - 223 048; Plein temps

Avantages offerts par ce poste

Hybrid work model

Exposure to senior leadership

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Clinical affairs

Clinical operations

Clinical science

Molecular diagnostics

IVD

Description du poste

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.

We know every background is different, but to be best set for success we see you bringing:

• 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.

You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.

Business recognition and accolades include:

• World's most innovative companies (Top 10)
• World's smartest companies (Top 50)
• 100 Best Places to Work in Boston
• Top 10 European Tech Startup
• Top 10 European biotechs startup to watch
• Top 25 East-Coast Biotech to watch

Our benefits package is comprehensive, but varies internationally in-line with local standards and laws. You can discuss a full breakdown with us, but as a brief overview:

• 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. Learn more about our DNA and Virtues on our Careers portal

The Process

We use the power of AI to help our partners make decisions. If you’re utilising AI in your search and application process, why not use some of these prompts, or read our AI guide.

‘What impact can I expect to have on the world by working at SOPHiA GENETICS?’

‘I have an interview with SOPHiA GENETICS. What should I know before I meet with them?’

‘I am a *job title* - What can SOPHiA GENETICS offer my career?’

Apply now with your CV and any supporting information.

Suitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader alongside key colleagues and stakeholders from across the business. If you need additional support for accessibility, please contact our TA team for assistance.

We appreciate the value external partners can bring, but we operate a direct-hiring model and we are not looking to utilize agency support at this time. All hiring is controlled by Talent Acquisition, potential partners should liaise through TA and not our hiring teams please.

Starting Date: ASAP

Location: Rolle, CH

Contract: Permanent