Tech Stack

Description

You will oversee CRO management and execution of clinical trials for novel RAS-targeted oncology therapies, ensuring adherence to GCP/ICH guidelines and program timelines. This role involves strategic planning, vendor oversight, and leading a clinical operations team to drive successful trial delivery.

Requirements

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

Responsibilities

• Oversee all aspects of clinical trials within timelines and budgets
• Develop and execute Clinical Development Plans (CDP)
• Manage and mentor Clinical Operations staff
• Oversee CROs and study vendors, evaluating performance with metrics and KPIs
• Lead cross-functional team meetings to achieve study goals