Clinical Development Transformation Lead

Job Summary

A company is looking for a Development Transformation Lead, Director.

Key Responsibilities

• Design and implement a comprehensive documentation framework for clinical trial processes
• Contribute to and implement R&D standards for controlled documents ensuring regulatory compliance
• Oversee external vendors and ensure alignment with strategic goals and timely deliverables

Required Qualifications

• Doctorate degree with 4 years of relevant experience, or Master's degree with 7 years, or Bachelor's degree with 9 years of relevant experience
• 10+ years of experience in clinical development, clinical operations, or clinical quality assurance
• Demonstrated experience in large-scale process transformation in a regulated environment
• Strong knowledge of controlled document management frameworks and inspection readiness principles
• Experience in vendor oversight and aligning process design with digital platforms for clinical trials