CDx Programme Leader (Director / Senior Director) at Sophia Genetics
London, England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

14 Nov, 25

Salary

0.0

Posted On

14 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Submissions, Working Experience, Programmes, Ema, Independent Contributor

Industry

Pharmaceuticals

Description

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.

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.
Responsibilities

Please refer the Job description for details

Loading...