Director, Clinical Operations – Phase III Oncology

Description: RemoteOur client is seeking a Director, Clinical Operations to lead the operational execution of a large global Phase III breast cancer study. The role will drive study start-up, site activation, vendor oversight, and cross-functional coordination across approximately 30 countries and 400 sites, advancing the program through key milestones toward database lock and regulatory submission. The Director will report to the VP of Clinical Operations and will operate in a fast-moving environment with established infrastructure from a prior Phase III breast cancer study using the same CRO and some overlapping sites. Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Lead operational execution of a global Phase III breast cancer study from start-up through regulatory milestones. Drive study start-up across ~30 countries and ~400 sites with tracked and achieved timelines. Provide sponsor oversight of CROs and vendors with clear expectations, deliverables, accountability, and escalation. Hold CROs accountable for contractual performance, milestones, quality, enrollment, and timelines. Identify risks and bottlenecks early and implement mitigation strategies. Coordinate cross-functional activities with Clinical Development, Data Management, Biostatistics, Regulatory, Safety, and Quality. Establish and monitor study-level metrics, milestones, risks, dependencies, and vendor performance. Oversee global site activation and start-up strategy. Drive operational decision-making with urgency appropriate for a pivotal program. Maintain inspection-readiness and documentation standards. Manage CRO and vendor escalation and intervene when performance or timelines are at risk. Provide concise status and risk reporting to Clinical Operations and senior leadership. Advance the study toward database lock and NDA/BLA submission. Operate effectively in a fast-moving biotech environment with high accountability. Experience Requirements 10+ years of progressive Clinical Operations or clinical research experience with significant sponsor-level leadership of global trials. Oncology experience required; breast cancer experience strongly preferred. Demonstrated leadership of large global Phase III studies across multiple regions. Direct experience leading a global Phase III study through late-stage execution and successful NDA and/or BLA submission. Proven experience taking a pivotal study over the finish line. Deep experience with study start-up and global site activation for complex late-stage trials. Extensive experience managing and overseeing global CROs and vendors. Ability to challenge CRO performance, escalate issues, and drive aggressive timelines and deliverables. Experience managing studies of significant size, complexity, enrollment, site footprint, and budget. Ability to anticipate study risks and implement mitigation and recovery strategies. Strong knowledge of ICH/GCP, inspection readiness, documentation, and global trial requirements. Ability to assume ownership with minimal ramp-up or onboarding. Strong leadership, communication, organizational, and cross-functional collaboration skills. Comfort operating in an execution-focused environment with aggressive timelines.