Director, Operations 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 116

Compensation Range:

$108,483.00 - $162,725.00

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 direct, oversee and coordinate all aspects of the Clinical Material Services Unit (CMSU) related to clinical supply operations and clinical pharmacy information services. Ensure compliance with Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs) standards meeting the requirements of FDA and ICH regulations and applicable professional standards pertaining to receipt, storage, inventory control, quality assurance, distribution, accountability and destruction of investigational drugs/devices. Collaborate closely with the Sr. Director and Director, Quality Assurance to ensure appropriate 21 CRF part 11 technologies are maintained at the CMSU (e.g. ClinPro LBL, temperature monitoring, etc.). Liaise directly with internal and external sponsors. Serve as a resource for clinical pharmacy information as needed in support during the planning and implementation stages of clinical studies. Manage operations of as the ‘central pharmacy’ for NIH, industry and other networks.

This position is responsible for developing, implementing, maintaining and providing leadership, strategic direction and oversight of compliance and training activities for FDA regulated research activities. The position ensures that all clinical research projects are carried out to the standards set forth by the International Conference of Harmonization (ICH) covering Good Clinical Practices (GCP), Good Manufacturing Practices

ESSENTIAL FUNCTIONS

• Direct the Clinical Supplies Operations Group: This 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. Ensure that resources and processes are in place to promptly respond to inquiries from site personnel. Ensure the CMSU is trained on other 21 CRF part 11 compliant technologies that will streamline CMSU activities (e.g., Interactive Response System (IRS)/Interactive Web Response System (IWRS). Also ensure the set-up of these technologies for each study is appropriate to meet the needs of the given clinical trial supply requirements.
• Responsible for all aspects of drug/device supply operations. Work in collaboration with CMSU leadership and Finance on business development, project management, budgets and financial activities relating to investigational and marketed product drug/device supplies, components and comparator/supplemental products.
• Management of CMSU Operations Personnel
• Recruit, train, and supervise Operations Group. 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 team and ensures that the CMSU facilities and equipment remain in full compliance with all NYS, Federal, and ICH regulations associated with GMPs, GCPs, GLPs, and other regulatory agencies (e.g. OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 & 211.
• Work in collaboration with CMSU Leadership and Project Manager to provide input and oversight in creation of study specific Clinical Material Specification Sheets (CMSS) and process orders (PO). Utilize GMP expertise and experience