Director, Operations CMSU

About the role

The Director, Operations CMSU leads the Clinical Material Services Unit at the University of Rochester, overseeing all aspects of clinical supply operations and pharmacy information services. This senior position ensures compliance with FDA, ICH, and Good Practice standards while supporting NIH, industry, and other research networks.

Key responsibilities

• Direct and coordinate receipt, storage, inventory control, labeling, distribution, accountability, and destruction of investigational drugs and devices in accordance with cGMP, GCP, and GLP.
• Maintain and oversee 21 CFR Part 11 compliant technologies such as ClinPro LBL and temperature‑monitoring systems.
• Liaise with internal and external sponsors, providing clinical pharmacy information during study planning and implementation.
• Collaborate with the Sr. Director and Director of Quality Assurance to ensure regulatory compliance and quality assurance.
• Manage the unit as the central pharmacy for NIH, industry, and other research networks, responding promptly to site inquiries.
• Develop, implement, and lead training and compliance activities for FDA‑regulated research.

Required profile

• Extensive experience in clinical supply chain management and regulatory compliance (cGMP, GCP, GLP, FDA, ICH).
• Proven leadership ability to oversee multidisciplinary teams and coordinate with sponsors.
• Strong understanding of 21 CFR Part 11 requirements and related technology platforms.
• Excellent organizational and communication skills to support complex research projects.

Required skills