A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: The role of the “Companion Diagnostics (CDx) Director“ is a strategic and scientific role with a focus on strategy, diligence and guidance pertaining to the definition and implementation of Companion Diagnostic (CDx) strategies with a special emphasis on Molecular Testing, specifically when Next Generation Sequencing (NGS) is applied. The candidate is leading a team of experts from different contributing functions including Regulatory affairs (drug related and also companion diagnostics related), Translational Innovation Platforms (TIPs), Global Clinical Operation (GCO), Global Clinical Development (GCD), Global Business Franchise (GBF) and other functions represented in the Global Product Team. The candidate is a senior leader and experienced in bringing molecular based companion diagnostics to market, throughout development and registration (preferably NGS-based). The candidate needs to be able to anticipate and mitigate risks, communicate in an open, transparent and timely manner, and take accountability in all CDx related aspects.
The position can be based in Darmstadt (Germany) or Billerica (USA).
Who you are:
- PhD or MD degree or equivalent preferred
- A minimum of approx. 5-10+ years in companion diagnostics, in vitro diagnostics, and Biomarker assay development (Oncology focus prefered)
- Strong understanding of the operational considerations in executing companion diagnostics strategies in clinical development is required
- Several years of experience in project management, preferably implementing biomarker technologies in clinical trials
- Understanding of clinical drug and companion diagnostics development strategies
- Strong understanding of the regulatory requirements for predictive biomarkers and derived CDx strategy
- Good understanding of quality-related requirements in companion diagnostics and drug development, in GXP-related areas.
- Demonstrated experience in molecular-based biomarker analysis, particular experience with next-generation sequencing assay design, validation and implementation is required
- Experience launching companion diagnostics into US, Japan and EU markets highly desirable
- Cross-functional collaboration, with transparent communication and program strategic oversight necessary
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com