Clinical Trial Strategy Director

Job Summary

A company is looking for a Director of Clinical Trial Strategy & Execution.

Key Responsibilities

• Provide strategic leadership and oversight for multiple clinical studies
• Define program deliverables and create long-range resource plans while ensuring appropriate resource allocation
• Oversee vendor and site budgets, negotiate for efficient resource use, and identify program risks

Qualifications

• Bachelor's degree in a life science; advanced degree is a plus
• Minimum 12 years of clinical experience, including 5 years managing cross-functional project teams
• Proven expertise in overseeing clinical trials and managing clinical programs
• Experience with FDA & EU regulations, ICH/GCP, and familiarity with BLA submissions
• Recognized as an influential thought-leader within the field