At a Glance
- Tasks: Lead innovative diagnostic programs and collaborate with cross-functional teams to improve patient outcomes.
- Company: Join a top-rated biotech firm focused on data-driven healthcare solutions.
- Benefits: Comprehensive benefits, relocation support, and a vibrant work environment.
- Other info: Dynamic workplace with opportunities for growth and direct interaction with senior leadership.
- Why this job: Make a real impact in cancer and rare disease diagnostics while advancing your career.
- Qualifications: 8+ years in IVD/CDx development and strong leadership skills required.
The predicted salary is between 90000 - 110000 £ per year.
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.
This role is attached to our Corporate HQ in Switzerland. For any individuals not based in Switzerland, this would require international relocation but this can be supported for suitably qualified individuals. This role cannot be done remotely from outside of Switzerland.
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.
We know that every background is different, but to be best set for success we see you bringing:
- 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.
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, fully 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.
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 or accommodations for accessibility, please contact our TA team for assistance on recruitment@sophiagenetics.com.
SOPHiA GENETICS recruiters only contact candidates from @sophiagenetics.com addresses and never request payment at any stage. Verify any offer before responding. 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: As suitable
Location: Rolle, CH (Hybrid) - International Relocation welcome
Contract: Permanent
Hybrid IVD/CDx Program Leader — Relocation Supported in Cambridge employer: SOPHiA GENETICS
SOPHiA GENETICS is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the biopharma sector. With a strong commitment to employee growth, we provide ample opportunities for professional development and career advancement, all while working remotely from the UK. Join us to be part of a forward-thinking team dedicated to transforming precision medicine and making a meaningful impact in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Hybrid IVD/CDx Program Leader — Relocation Supported in Cambridge
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like SOPHiA GENETICS. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like SOPHiA GENETICS!
We think you need these skills to ace Hybrid IVD/CDx Program Leader — Relocation Supported in Cambridge
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show SOPHiA GENETICS that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at SOPHiA GENETICS.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that SOPHiA GENETICS does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at SOPHiA GENETICS
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at SOPHiA GENETICS. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into SOPHiA GENETICS's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at SOPHiA GENETICS. This shows your passion for the industry!
