Director of Operations, Clinical Materials Services Unit

About the role

The University of Rochester seeks a Director of Operations for its Clinical Materials Services Unit (CMSU). This senior leader will oversee all aspects of clinical supply operations, ensuring compliance with regulatory standards and supporting a wide range of NIH, industry, and network‑based research studies.

Key responsibilities

• Direct the Clinical Supplies Operations Group, managing receipt, storage, labeling, distribution, accountability, and destruction of investigational drugs and devices.
• Ensure compliance with cGMP, GCP, GLP, FDA, and ICH regulations throughout the supply chain.
• Collaborate with the Sr. Director and Director of Quality Assurance to maintain 21 CFR Part 11 technologies such as ClinPro LBL and temperature monitoring systems.
• Liaise with internal and external sponsors, providing pharmacy information support during study planning and implementation.
• Develop, implement, and oversee training and compliance activities for FDA‑regulated research.

Required profile

• Senior‑level experience in clinical supply chain or pharmacy operations within a research environment.
• Proven track record of leading teams and managing complex regulatory compliance.
• Strong understanding of FDA, ICH, cGMP, GCP, and GLP requirements.
• Excellent communication and stakeholder management skills.

Required skills

• cGMP compliance
• GCP compliance
• GLP compliance
• FDA regulatory knowledge
• ICH guideline expertise
• 21 CFR Part 11 systems
• ClinPro LBL
• Temperature monitoring systems

What we offer

• Competitive salary range of $108,483 – $162,725 annually.
• Full‑time, permanent position with a supportive academic environment.
• Opportunities to lead high‑impact clinical research initiatives.