Director Clinical Operations

A well-capitalized oncology biotech with approved assets and late-stage pipeline momentum is looking for a Director of Clinical Operations to lead program execution across its clinical portfolio. This is a high-ownership role in a lean, fast-moving environment where your work directly shapes trial outcomes. What you will own Lead end-to-end operational strategy and execution across one or more oncology clinical programs, from protocol development through database lock and regulatory submission Partner with cross-functional teams to develop and maintain clinical program plans, timelines, and budgets in alignment with corporate milestones Oversee CRO and vendor selection, governance, and performance management to ensure delivery against scope, quality, and financial commitments Ensure clinical trials are conducted in compliance with ICH/GCP, FDA requirements, and applicable SOPs; maintain a constant state of inspection readiness Serve as a senior operational voice on the clinical development team, contributing to protocol design, risk identification, and mitigation planning Provide leadership and mentorship to clinical operations staff, building a culture of accountability, transparency, and continuous improvement Support authoring and review of key regulatory and clinical documents, ensuring alignment with submission requirements and agency expectations What we are looking for A minimum of 10 years in clinical trial management and operational leadership Proven Phase 3 global program execution in oncology or rare disease; small-to-midsize biotech experience strongly preferred Deep CRO and vendor oversight experience with demonstrated budget management and milestone accountability Strong working knowledge of ICH/GCP, FDA/EMA regulatory requirements, and inspection readiness best practices #J-18808-Ljbffr The Lotus Group LLC