3h ago
Senior Director, Oncology Clinical Trial Operations
San Carlos, CA
full-timedirectorOncology / Biotechnology
Description
You will lead the strategic planning and operational execution of oncology clinical trials for Natera's oncology products, focusing on interventional studies. Your role includes feasibility assessment, enrollment modeling, timeline forecasting, budget management, and end-to-end study execution to support regulatory and commercial objectives.
Requirements
- Proven program management leadership in oncology clinical trials.
- Experience with interventional studies and regulatory submissions (PMA, 510(k), CE Mark).
- Strong CRO and vendor management skills.
- Knowledge of GCP compliance and inspection readiness.
- Ability to lead cross-functional teams and develop scalable operational frameworks.
Responsibilities
- Lead operational execution of oncology clinical trials for regulatory submissions and publications.
- Conduct feasibility assessments, enrollment projections, and operational complexity analysis.
- Oversee CRO selection, scope development, and performance management.
- Develop site selection strategies, manage lab readiness, and ensure GCP compliance.
- Manage budgets, track actuals against forecasts, and hire/oversee study teams.
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