Description

You will oversee CRO management and execution of clinical trials in oncology, ensuring compliance with GCP and regulatory guidelines. You'll lead risk management, vendor oversight, and cross-functional collaboration to advance novel RAS-targeted therapies for patients with RAS-addicted cancers.

Requirements

• RN or Bachelor's/Master's in biological sciences or health-related field
• 11+ years Clinical Operations experience in pharma/biotech
• 5+ years project and first-line management experience
• Experience in oncology and global phase 1-3 clinical trials
• Working knowledge of FDA Regulations, ICH Guidelines, and GCP

Responsibilities

• Oversee CRO and vendor performance, ensuring delivery within timelines and budgets
• Lead risk management and quality efforts for study compliance and inspection readiness
• Manage Clinical Operations staff including hiring, performance management, and mentorship
• Lead cross-functional team meetings and collaborate with Clinical Development, Regulatory, QA, etc.
• Contribute to Clinical Development Plan strategy: timelines, budget, resource requirements