CDx Programme Leader (Director / Senior Director)

SOPHiA GENETICS; Rolle; Hybrid; CHF 120’000 - 160’000; Vollzeit

Zusammenfassung

A leading biotech company in Switzerland is seeking a CDx Programme Leader to drive the development and implementation of Companion Diagnostic programmes. You will influence cross-functional teams and work closely with stakeholders to ensure regulatory compliance. Ideal candidates have over 7 years of relevant experience in diagnostics and possess a successful, solutions-oriented mindset. This role offers a flexible, hybrid work environment.

Leistungen

Flexible work hours

International work environment

Comprehensive health benefits

Qualifikationen

• 7+ years of experience in companion diagnostic development.
• Direct exposure to analytical validation studies for regulatory submissions.
• Experience in international programs within the pharmaceutical industry.

Aufgaben

• Develop and execute CDx frameworks aligned with precision medicine initiatives.
• Collaborate cross-functionally to drive CDx programs.
• Partner with external organizations for advancing CDx programmes.

Kenntnisse

Experience with Companion Diagnostics development

Regulatory compliance understanding

Cross-functional leadership

Stakeholder management

Ausbildung

Relevant degree in life sciences or related field

Jobbeschreibung

Do you bring direct experience driving CDx programmes through various stages in development? Have you got a highly commercialised mindset, with a plan-and-deliver approach?

If this sounds like you and you are driven by purpose, Join the SOPHiA GENETICS BioPharma Business Development & Operations team as our CDx Programme Leader (Director / Senior Director), and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.

Ideally, you will be in proximity to our Switzerland (Rolle) Corporate offices on a hybrid work-schedule to partner closely with key stakeholders locally, however suitably qualified candidates can be considered across the UK or EU5.

Candidates from the US-East Coast may be considered, but due to high collaboration and team structure within Europe, this role wouldn't suit someone working remotely from the US West Coast or Central states.

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.

Through a decentralized global network and patented algorithms, we give the BioPharma community access to high quality NGS solutions, Biomarker Discovery, Clinical Trial Assays and CDx leveraging the SOPHiA DDM platform, including the ctDNA-based LBx solution MSK ACCESS powered with SOPHiA DDM.

This role sits as part of our BioPharma Diagnostics Team. Learn more about SOPHiA DDM BioPharma Solutions here.

Your Mission

Reporting to the Managing Director, BioPharma Solutions, you will be a cross-functional leader responsible for driving the development and implementation of Companion Diagnostic (CDx) programmes globally. You will influence cross-functional teams to develop companion diagnostics that identify patients most likely to benefit from specific therapeutic interventions while ensuring regulatory compliance and commercial viability.

The value you add:

• Strategic Leadership - Develop and execute comprehensive Companion Diagnostic (CDx) frameworks aligned with SOPHiA GENETICS' precision medicine initiatives; leading the end-to-end development of CDx projects from concept through regulatory approval and commercialization
• Cross-functional collaboration & leadership - Collaborate cross-functionally as an influencing leader to successfully drive CDx programmes through development including Product Development; Genomic Research; Bioinformatics; Regulatory & Clinical Affairs and Business Development
• Stakeholder Management - Partner externally with pharmaceutical organisations & diagnostics companies to advance Companion Diagnostic Programmes
• Regulatory - Partner with Regulatory Affairs to support regulatory submissions for CDx approval including FDA, IVDR, PMDA; Design and execute clinical validation strategies that demonstrate clinical utility and analytical performance

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

• 7+ Years working experience within companion diagnostic development, biomarket strategy or similar precision medicine
• Direct experience driving CDx development plans and activities through to successful partnership.
• Additional experience in IVD Clinical Dx beneficial.
• Direct exposure to analytical validation studies for regulatory submissions, with a comprehensive understanding of CDx Regulatory Frameworks within FDA & IVDR/EMA (Minimum) PDMA/NMPA (valuable)
• Direct working experience driving programmes globally/internationally (US & EU minimum); Further experience in single-site CDx programmes is also valuable, but single-site experience alone is not enough.

• This role may suit someone previously with Clinical Diagnostics (Dx) that has additional experience within Pharma, or someone that has grown within Pharma with exposure to precision medicine looking to move towards Dx. Experience in Clinical Diagnostics (Dx) alone, without exposure to Companion Diagnostics (CDx) is not proficient.
• Whilst influencing and leveraging cross-functional teams, this is an independent contributor and the build-and-deliver nature of this role means you need to be comfortable delivering personally.

As a public organisation facing ongoing commercial growth, you will bring a success-orientated and solutions-focused mindset that embraces team collaborations, change, growth and inclusion.

As an international organisation, English is our primary business language and you will need to bring full fluency in English. As part of your recruitment journey, you should expect to meet English-only speakers, so for best chances of success, you should include your CV in English. Non-English CVs have a high likelihood of being rejected at application stage.

You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth to our new business unit.

Business recognition and accolades include:

Fast Company's World's most innovative companies (Top 10)

World's smartest companies (Top 50)

Best Places to Work in Boston (2023 & 2024)

Top 10 European Tech Startup

Top 10 European biotechs startup to watch

Top 25 East-Coast Biotech to watch

Benefits:

A flexible, friendly and international working environment with a collaborative atmosphere
An exciting company mission that brings together science and technology to directly impact the lives of patients with life-threatening illness.

Career opportunities in a fast-growing company with a worldwide reputation

International and multicultural environment - work with colleagues around the world

Flexible hours, HYBRID work schedules

Exchanges and collaborations with experts within the company (AI, genomics, medicine, etc.)

Passionate colleagues working to make a real difference in patient care. Help us change the world!

The Process
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.

Starting Date: ASAP

Contract: Full-Time, Permanent

Location: Hybrid; Boston or Rolle.

You will be joining an organisation 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:

US:

• Outstanding Medical, Dental & Vision with 90% Employer Contribution
• Company matched 401K at 4%
• Company-paid short & long-term disability insurance
• FSA commuter benefits
• 20 Days PTO, increasing to 25 with tenure; 5 Days Sick and 14 Public Holidays
• Employee Assistance Programme free for all colleagues

CH

• 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 utilise 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; Hybrid Work Schedule (Preferred) Remote UK/EU5 (Secondary)

Contract: Permanent, full time