Clinical Operations Compliance Director (Biotechnology Oncology)

SUMMARY/JOB PURPOSE The Clinical Operations Compliance Director is responsible for ensuring that oncology clinical research activities are conducted in accordance with ICH GCP, applicable international and local regulations, industry standards, and Exelixis policies and procedures. This role provides strategic and operational leadership for compliance related activities within Clinical Operations, with a focus on risk management, issue management, CAPA oversight, vendor oversight, site and data monitoring practices and inspection readiness. This role serves as a key partner to Quality Assurance and cross-functional stakeholders across Clinical Development, Data Management, Biometrics, Regulatory Affairs and other R&D functions. The Director drives consistency in clinical trial execution, promotes proactive risk identification and mitigation, supports audit and inspection readiness, and enables continuous process improvement through analysis of compliance metrics, trends and operational data. The Director influences organizational compliance strategy, contributes to the development and implementation of standardized processes and tools, and provides leadership in resolving complex compliance and operational challenges across the clinical development portfolio. ESSENTIAL DUTIES/RESPONSIBILITIES Lead the execution and continuous improvement of the Clinical Operations risk and issue management program to support compliant and efficient study conduct. Partner with Clinical Operations leadership and cross-functional stakeholders to identify, assess, mitigate and escalate risks impacting clinical trial quality, compliance and execution. Contribute to the development and implementation of functional risk management strategies and annual risk management plans to support inspection readiness. Review, analyze and communicate compliance trends, quality metrics, key risk indicators, and inspection readiness measures to functional leadership. Support the management and oversight of CAPAs, ensuring appropriate ownership, tracking, timely completion and effectiveness evaluation. Provide regular updates and recommendations to Clinical Operations leadership regarding CAPA status, compliance risks, trends and emerging issues. Collaborate closely with Quality Assurance to support internal audits, regulatory inspections, inspection readiness activities and follow-up actions. Drive cross-study consistency in clinical trial execution through the development, implementation and adoption of standardized processes, templates and best practices. Facilitate the identification and resolution of significant operational and quality issues and ensure appropriate escalation through governance structures. Support oversight of clinical vendors and CRO partnerships to ensure adherence to quality and compliance expectations. Utilize operational and compliance data to identify opportunities for process improvement, risk reduction and enhanced quality management. Serve as subject matter expert for Clinical Operations compliance-related processes and provide guidance, training and consultation to functional stakeholders. Partner with leadership across R&D to foster a culture of quality, inspection readiness and proactive compliance management. Will be responsible for one or more areas: Training, Capability & Analytics - Build a standardized GCP and process training curriculum, drive ongoing capability and knowledge-sharing and build and renew quality metrics to track progress and consistency across Clinical Operations. BIMO & Inspection Readiness - Drive continuous inspection readiness across studies, keep TMF audit-ready, run mock inspections and CAPA follow-up and lead BIMO and health authority inspection response. RBQM/RBM & Monitoring Oversight - Oversight of monitoring quality and CRO performance, risk-based monitoring signals and timely escalation of site and data issues. Performs other duties as assigned Complies with all policies and standards SUPERVISORY