Executive / senior industry position
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.
- 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
Working time model: full-time
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