Senior Director, CMSU

University of Rochester • Satsuma, FL

7d • Onsite

About The Position

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. 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).

Requirements

• Masters degree required
• 12 years’ experience in clinical research, biopharma drug development, and/or healthcare industry experiences or equivalent combination of education and experience required
• 8 years’ proven leadership experience required.
• Minimum of 8 years of proven, effective strategic planning; analytical problem solving and decision making; managerial and leadership skills and experience; or equivalent combination of experience and education required
• Excellent understanding of regulatory requirements (e.g., GMP, GCP, HSPP, ICH) and Audit readiness
• Strong organizational, interpersonal, presentation and communication skills, including written communications
• Ability to model leadership skills of professionalism, positive attitude, team building, good judgment and respect

Nice To Haves

• At least 20+ years of experience in the industry strongly preferred.
• Ability and knowledge to discuss scientifically with biopharma R&D/Medical Directors/Clinicians/PIs, commercial/operational experiences with biopharma(s) with relationships/connections in the clinical research industry/associations are preferred
• Strong acumen to understand and drive adoption of technologies, in particular clinical data management, data visualization, and statistics in clinical trials preferred

Responsibilities

• 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 on appointments, promotion, salary or other related personnel issues. Responsible for ongoing and yearly performance evaluations of direct reports. Provides direction to individual staff members for staff development through personal instruction and scheduling participation in professional meetings, institutes, and seminars.
• Oversee and help manage Director Operations production/client responsibilities and Director Quality Assurance for GMP, Compliance, and Regulatory requirements.
• Budgets/Capital Expenditures: Annually, in conjunction with the CHET Financial Controller, and Research Associate Professor develop the CMSU operational budget and manage to it. Assure revenues to maintain financial viability. Responsible to ensure that the CMSU’s time and effort is accurately reported by project to the CHET financial controller for billing to each project. Responsible for identifying opportunities for cost savings and revenue enhancements.
• Additional projects and responsibilities: as needed including but not limited to serving as a key member of the CHeT leadership team to discuss operations and logistics and the integration of CMSU in CHeT operations Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Director