Clinical Operations Compliance Director (Biotechnology Oncology)

Role: Clinical Operations Compliance Director overseeing oncology clinical research compliance with ICH GCP, international, and local regulations. Responsibilities: lead risk management, issue resolution, CAPA oversight, vendor management, and inspection readiness; collaborate with QA, Data Management, Biometrics, and Regulatory teams; develop and implement standardized processes; monitor compliance metrics and trends; support audit and inspection activities; oversee training and oversight of clinical vendors and CROs. Requirements: Bachelor's degree with 13+ years (or advanced degree with fewer years) in biotech/pharma industry; experience in R&D outsourcing, CRO management, or procurement; strong leadership, communication, and collaboration skills; deep knowledge of GxP, industry standards, and regulatory environment. HighValue: oncology clinical research, risk-based monitoring, inspection readiness, vendor oversight, compliance management, cross-functional stakeholder engagement, leadership in clinical operations. WorkSetup: not specified; requires strategic leadership and cross-functional influence.