Director of Clinical Supply

Job Summary

To support global clinical studies, the full-time Director of Clinical Supply will manage planning and execution of Clinical Supply Chain activities, oversee contract manufacturing operations, and ensure compliance with cGMP requirements while working remotely.

Key responsibilities

• Directly oversee contract manufacturing packaging, labeling, and international distribution operations for Investigational Medicinal Products (IMP)
• Manage, coach, and mentor Clinical Supply Managers while acting as the primary liaison with contractors
• Establish SOPs and protocols for clinical trial material packaging and distribution to ensure compliance with cGxP requirements

Required qualifications

• Minimum of 8 years of experience in the pharmaceutical industry, with at least 5 years in Global Clinical Supply Management
• Prior investigational drug product experience and GCP training required
• Demonstrated experience with global clinical supply forecasting and planning
• Thorough knowledge of cGMP, ICH/cGXP guidelines, and global Health Authority requirements
• Proficiency in relevant software such as IVRS/IWRS, Excel, PowerPoint, and MS Project