Senior Director, CMSU

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

150 Metro Park, Rochester, New York, United States of America, 14623

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400982 Neuro-Ctr Health & Tech/CMSU

Work Shift:

UR - Day (United States of America)

Range:

UR URG 118

Compensation Range:

$140,350.00 - $210,525.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

To provide on-site leadership and management of the overall operations of the Clinical Materials Services Unit (CMSU), consisting of approximately 15 team members, with two Directors (Director, Operations and Director, Quality Assurance) and the clinical trials it supports in North America. This role will oversee teams and ensure maximum operational efficiency, resource utilization and overall regulatory and cGMP compliance with all applicable state and federal regulations, licensing requirements, and professional standards, including cGMP facility oversight, pertaining to secondary packaging, labeling, blinding, distribution and return services of clinical supplies (drugs and devices).

ESSENTIAL FUNCTIONS

• Oversee all aspects of CMSU day to day operations and on-site staff, including operations and quality assurance teams, project prioritization, resource allocation, and day-to-day operations efficiency.
• Set and implement the overall direction of the CMSU in conjunction with the Research Associate Professor, its growth and diversification strategy, including prioritizing CMSU projects and resource allocation,management and administration of other operations (e.g., prepare analyses and reports, make recommendations for programs and policies, etc.) and business development and partnership with all internal and external partners.
• Oversee and support facilitation of all facilities responsibilities managed by the Facilities Coordinator (dotted reporting relationship to Director Operations), including but not limited to manage relationship with landlord, facilitate and manage any matters related to the lease. Maintain all critical equipment, such as freezers/refrigerator/cold room, temperature controls via current enterprise software, generator, labeling software and printers in accordance with cGMP requirements. Ensure Pest control program is adequate and well documented and any facality repairs/upgrades are completed per cGMPs (e.g HVAC, roof leaks, loading dock, doors). Ensure overall security of the facility.

Drive key strategic initiatives, including:

• Recruiting, developing, training, and retaining strong talent
• Driving improvements in infrastructure, technologies, operating systems, and processes
• Developing and executing strategic technology roadmap that enable efficient operations
• Delivering transparency into operations – e.g., self-serve reporting for client, timeline/resource dashboard to manage project timeline & optimize resource allocation
• Management of the performance and productivity of CMSU Functional Directors and the functional groups (Clinical Supplies Operations Group; Quality Assurance Compliance Group).
• The Clinical Supplies Operations Group is responsible for receipt of all incoming materials, inventorying, warehousing, packaging, labeling, distribution, accountability and returns destruction of all investigational drug/device supplies, including components, comparator products and supplements in compliance with cGMPs.
• The Quality Assurance Compliance Group oversees all aspects of Good Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices associated with CMSU to comply with Federal, State and ICH Regulations and other regulatory authorities as applicable.

Management and development of CMSU Staff

• Recruit, train, develop, and supervise
• Recommends or approves action