Head Of Clinical Science, Clinical Development
Current-Headed and established Clinical Science as a new functional department at Kite, responsible for all registrational clinical studies in cell therapy and oncology. -Created a vision for the Clinical Science function: cross-functionally vetted role definition, new and revised procedural documents to reflect role responsibilities, training curriculum, clinical science standards, career ladder and hiring plan.-Represented Clinical Science on the cross-functional Kite Development Leadership Team.-Provided technical leadership and strategic input into attaining Kite’s clinical development goals including regulatory filings for new products, notably the Yescarta 2L LBCL approval.-Introduced the patient profile and medical data review rules as a package for standardized, disease specific, case level cleaning and milestone locking: a new Kite standard.-Architected the successful integration of the manufacturing and clinical databases and integrated voice/web response system to establish single source of truth for patient data and to enable multi-use integrated automation. Key benefits included: 1) Stratification factor cleaning and locking before transfer to IxRS for patient randomization; thus, eliminating reconciliation between systems and adding a strong quality control step. 2) Expedited manufacturing slot assignment and release; thus, creating a cell therapy manufacturing competitive advantage.- Drove consistency and best practice for data collection, cleaning, and analysis as a voting member of the Standards Governance Committee (CRFs, CCGs, edit checks, dynamics, TLGs).
