Responsibilities

• Develop and implement companion diagnostic strategy covering preclinical to clinical trial stage to support CStone pipeline especially ADC assets
• Oversee all technical aspects of assay development, assay validation and clinical implementation of the selected assays.
• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements
• Works with asset leads to ensure efficient implementation of all key deliverables for the CDx
• Provides frequent project status updates related to CDx deliverables
• Keep up-to-date with the latest molecular diagnostics and precision medicine advancements and keep informed about current trends in oncology and immune oncology therapeutics development to ensure access to state-of-art thinking/approach
• Provide day-to-day scientific, technical and organizational leadership to molecular diagnostics assay technology and manage a portfolio of programs to achieve scientific and operational excellence with strong impact on clinical development
• Work with bioinformatics and translational medicine and biomarker science to provide technical inputs to external diagnostic company vendor selection and biomarker assay validation, sample management, and data analysis conducted in laboratories for all stages of drug development
• Incumbent will report to the Head of Molecular Diagnostics

Desired Experience and Skills

• Ph.D. in the Biological Sciences and 3 years of oncology industry experience or M.S. with 6 years of oncology industry experience
• Good knowledge in primary antibody development and IHC-based assay validation, WB, ELISA, PCR and NGS technology
• Strong leadership in interacting with multiple internal and external stakeholders
• Fluent English listening, speaking, reading and writing skills