Job Description
About the opportunity
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