Director of Clinical Operations

Job Summary

A company is looking for an AD/Director, Clinical Operations.

Key Responsibilities

• Represent Clinical Operations at cross-functional teams and manage study planning and execution
• Oversee clinical trials from start-up through close-out, including financial tracking and reporting
• Manage relationships with CROs/vendors, including budget oversight and risk mitigation activities

Required Qualifications

• BA/BS in a scientific or medical field or equivalent work experience
• At least 10+ years of experience managing global clinical trials in the biopharma industry
• Significant experience with cross-functional leadership and clinical data management
• Experience with BLA preparation, FDA submissions, and audit readiness
• Strong knowledge of GCP and ICH GCP E6 R2 regulations