Basel, Switzerland
Solution oriented leader with 15+ years industry experience in diagnostic and drug (co-) development across therapeutic areas and technologies. Deep expertise in developing novel companion diagnostic (CDx) and PHC solutions for clinical research and clinical practice. Strong understanding of the drug development process and associated scientific, regulatory, and operational requirements of diagnostic device development and clinical validation. Experience in developing and implementing portfolio level CDx strategies and navigating evolving diagnostic regulatory requirements. Collaborative leader in a matrixed environment with strong, strategic networks across the Roche enterprise (pRED, gRED, PD, Chugai, Roche Diagnostics, FMI). Several years of experience in matrix leadership, building and leading teams and line management across cultures and geographies.
• Manage overall Roche pRED companion diagnostics (CDx) portfolio • Responsible for development and implementation of overarching pRED CDx and PHC strategy. • Define CDx development paths that provide fit-for-purpose diagnostic solutions that balance risk, timeline and investment, and enable seamless transitions from early to late stage clinical development. • Diagnostic regulatory strategies to ensure compliance with evolving global regulatory requirements (e.g. EU IVDR). • Provide leadership and guidance to Roche pRED PHC (Personalized Healthcare) and Companion Diagnostics (CDx) Strategy Team. • Build and foster strategic collaborations and interfaces across the Roche enterprise and with Roche internal and external diagnostic partners as well as academic collaborators.
- Alberta Glycomics Centre - Development of Carbohydrate and Glycopeptide based anti-tumor vaccines