Director of Operations, Clinical Material Services Unit

About the role

The University of Rochester seeks a Director to lead the Clinical Material Services Unit (CMSU). This senior position oversees clinical supply operations, ensures regulatory compliance, and supports clinical pharmacy information services across NIH, industry, and partner networks.

Key responsibilities

• Direct all aspects of CMSU, including receipt, storage, inventory control, labeling, distribution, accountability, and destruction of investigational drugs and devices.
• Maintain compliance with cGMP, GCP, GLP, FDA, and ICH regulations.
• Collaborate with the Sr. Director and Director of Quality Assurance to manage 21 CFR Part 11 technologies such as ClinPro LBL and temperature monitoring systems.
• Liaise with internal and external sponsors, providing clinical pharmacy information during study planning and implementation.
• Provide strategic leadership for training and compliance activities related to FDA‑regulated research.

Required profile

• Extensive experience in clinical supply chain management or related pharmaceutical operations.
• Strong knowledge of FDA, ICH, cGMP, GCP, and GLP standards.
• Proven ability to lead multidisciplinary teams and manage large‑scale operations.

Required skills

• 21 CFR Part 11 compliance
• ClinPro LBL system
• Temperature monitoring technologies

What we offer

• Competitive salary range of $108,483 – $162,725 per year.
• Full‑time, 40‑hour work week in a collaborative academic environment.
• Opportunities for professional growth within a leading research institution.