Key Responsibilities: • Drive the development, optimization, alignment and implementation of clinical trial processes across Kite Clinical Development • Partner with equivalent Client functions for development, optimization and alignment of shared clinical trial processes • Identify and Lead Process Improvement opportunities at Kite • Establish and maintain the training curricula for Clinical Operations and support other Clinical Development functions, as needed • Develop Onboarding plans for Clinical Operations • Support transition planning within Clinical Operations as needed • Proactively monitor compliance with Clinical Operations procedural documents and training requirements • Develop and report process and training compliance metrics • Support and participate in internal audits and regulatory authority inspections, as needed • Support audit/inspection response development and CAPA implementation, as needed • Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary • Lead and support efforts to increase compliance awareness and a culture of compliance
Knowledge & Skills: • In depth knowledge of international GCP regulatory requirements • Deep understanding of end-to-end clinical trial processes • Organizational Awareness • Independently lead and manage cross-functional initiatives • Excellent communication skills, provide clear and concise instructions • Negotiate sensitive issues in an objective manner • Critical and creative thinking to be able to resolve complex problems • Ability to prioritize and adjust workload to meet evolving department and regulatory needs • Lead by example to champion quality and compliance.