Senior Program Leader (IVD/CDx)

SOPHiA GENETICS; Rolle; Hybrid; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Hybrid work schedule

International relocation support

Zusammenfassung

SOPHiA GENETICS is seeking a Program Leader for Diagnostics Solutions in Rolle, Switzerland. The hybrid role focuses on end-to-end IVD/CDx development programs, coordinating cross-functional teams through validation, regulatory submissions, and commercial launch.

You will collaborate with Biopharma partners, manage budgets, and drive alignment across development, regulatory, and clinical workstreams to meet IND/CE/MII timelines. International relocation is supported.

Qualifikationen

• 8+ years in diagnostic product development or program ownership across IVD/CDx or clinical assays.
• Track record delivering IVD/CDx programs through FDA approval or CE marking or pivotal trials.
• Deep knowledge of IVD/CDx development including validation, design controls, regulatory interactions, and global strategy.
• Experience managing budgets, resources, and multi-partner biopharma programs.
• Strong communication, negotiation and cross-functional leadership.
• Familiarity with EU IVDR and FDA requirements preferred.
• Oncology experience and hands-on diagnostics platform expertise preferred.
• BS required; PhD/MSc preferred.

Aufgaben

• Lead end-to-end strategic and operational leadership of one or more IVD/CDx development programs, including Clinical Trial Assays and companion diagnostics.
• Coordinate cross-functional teams across development, verification/validation, clinical, regulatory, quality, manufacturing and product management.
• Manage biopharma partnerships with clear governance, risk management, and on-time milestone delivery.
• Ensure alignment of validation, regulatory submissions, and drug development timelines with partner plans.
• Deliver programs from requirements to regulatory submission and commercial launch.

Kenntnisse

IVD development

CDx development

Cross-functional leadership

Regulatory strategy

Biopharma partner management

Technical communication

Problem solving

Ausbildung

B.S. degree or equivalent

Advanced degree (PhD/MSc) preferred

Jobbeschreibung

Do you bring deep experience in IVD or companion diagnostic product development and a track record of leading complex programs through regulatory approval or pivotal clinical trials? Can you align cross-functional teams and biopharma partners around the scientific, regulatory, operational, and commercial milestones needed to deliver diagnostic solutions?

If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Diagnostics Solutions team as a Program Leader 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, CH corporate office. International relocation can be supported for this opportunity.

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 Program Leader, you will be accountable for the end-to-end strategic and operational leadership of one or more in vitro diagnostic development programs, including Clinical Trial Assays, tumor profiling tests, Companion Diagnostics, and software as a medical device. You will ensure programs are co-developed, validated, and submitted on time and in alignment with each biopharma partner’s drug development timeline. This role requires deep knowledge of IVD and CDx development, strong biopharma customer management skills, and the ability to orchestrate cross-functional teams across development, verification and validation, clinical, regulatory, and commercial workstreams.

The value you add

• Define and own the design and development strategy for IVD, CTA, tumor profiling, CDx, and/or SaMD programs, aligning analytical and clinical validation and regulatory timelines with biopharma drug development milestones, including IND, Phase I/II/III, BLA, NDA, and MAA.
• Build trusted biopharma partnerships as the primary project contact, maintaining transparency on status, risks, decisions, co-development agreements, technical feasibility scopes, and joint development plans in collaboration with Biopharma Business and Legal.
• Lead internal and joint governance—including portfolio reviews, business stage gates, design reviews, Joint Steering Committees, and Joint Development Teams—to drive aligned, timely decision-making.
• Integrate Bioinformatics and Assay Development, Verification and Validation, Clinical Operations, Regulatory Affairs, Quality Assurance, Manufacturing, Product Management, and Biopharma teams around a coherent program strategy, milestones, resources, and shared accountability.
• Deliver diagnostic programs from requirements definition through product development, verification and validation, regulatory submission, and commercial launch while managing timelines, budgets, risks, resources, and contingency plans.

Requirements

• 8+ years of experience in diagnostic product development or program/project ownership across IVD, CDx, or clinical laboratory assays, including at least 3 years in cross-functional project or program leadership.
• A demonstrated track record of delivering an IVD or CDx program through FDA approval or CE marking, or a CTA through a pivotal clinical trial.
• Deep knowledge of IVD and CDx development, including assay and bioinformatics development, analytical and clinical validation, design controls, regulatory interactions, and global regulatory strategy.
• Experience managing budgets, resource planning, technical and regulatory risks, and complex external biopharma partnerships in a matrixed, multi-partner environment.
• The ability to move between high-level business strategy and tactical daily program operations, supported by strong technical communication, influencing, negotiation, and conflict-resolution skills.
• A solid understanding of drug-diagnostic co-development and the regulatory interdependencies between CDx and drug approval; familiarity with EU IVDR and FDA requirements is preferred.
• Oncology therapeutic area experience and a hands‑on technical background in one or more diagnostic platforms are preferred.
• A B.S. degree or equivalent is required; a PhD, MSc, or equivalent degree in molecular biology, biochemistry, analytical chemistry, genomics, pathology, or a related life sciences discipline is preferred.

Benefits

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 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?

Starting Date: As suitable

Location: Rolle, CH (Hybrid) - International Relocation welcome

Contract: Permanent