Senior Director, Head of Global Clinical Process Management - Remote

Overview

The Head of Global Clinical Process Management is responsible for designing, implementing, and optimizing processes across multiple locations or regions, focusing on enhancing efficiency and quality in clinical operations.

In Short

• Lead efforts to ensure clinical operations process excellence.
• Conduct gap analyses and operationalize mitigation strategies.
• Evaluate and implement solutions for operational gaps.
• Optimize clinical operations processes and maintain document lifecycle management.
• Support organizational change management efforts.
• Facilitate leadership alignment of cross-functional SOPs.
• Develop and maintain governance charters and processes.
• Monitor key metrics and address gaps in processes.
• Work with CRO partners for seamless integration of activities.
• Lead and develop staff through mentoring and performance management.

Requirements

• Bachelor’s Degree with minimum of 12+ years in pharmaceutical or biotechnology drug development.
• Experience in clinical operations, process, quality, or compliance roles.
• Strong written and verbal communication skills.
• Deep expertise in end-to-end clinical trial processes.
• Experience in process design and optimization.
• Six Sigma certification or experience with process mapping tools.
• Knowledge of regulatory requirements (FDA, EMA).
• Experience in a cross-functional, global environment.
• Strong leadership and collaboration skills.
• Understanding of industry trends related to regulatory and technology.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision.
• 401(k) and FSA/HSA options.
• Life Insurance and Paid Time Off.
• Wellness programs.
• Opportunity to participate in equity awards.
• Annual bonus plan for Non-Commercial roles.
• Incentive compensation plan for Commercial roles.
• Equal opportunity employer with a commitment to diversity.
• Support for reasonable accommodation in the application process.
• Global team with opportunities for career growth.