Executive Director, Clinical Operations Excellence

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to the formulation of strategies for Clinical Development & GCO.

• Oversee compliance management frameworks and processes within GCO.

• Ensure compliance with regulatory standards and GCP/PV directives.

• Establish and guide teams focused on continuous improvement initiatives.

• Develop and report on clinical performance metrics (KPIs/KQIs).

• Supervise compliance monitoring and prepare for regulatory inspections.

• Mentor and cultivate the development of both direct and indirect reports within GCO.

⛳️ Requirements

• Bachelor’s degree in a scientific or healthcare field; advanced degrees are preferred.

• More than 15 years of experience in the biotech, pharmaceutical, or CRO sectors within Clinical Operations.

• Proficient with Microsoft Word, Excel, Project, PowerPoint, and Outlook.

• Fluent in English, both written and spoken.

• Knowledge of Mandarin is a plus.

• Experience in developing GCP quality systems and processes.

• Strong capabilities in leadership and risk management.

• Expertise in Project Management, Root Cause Analysis, and CAPA Management.

• Preferred familiarity with Six Sigma, LEAN, and Agile methodologies.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness