Director, Operations CMSU

University of Rochester • Satsuma, FL

3d • 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 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

Requirements

• BS degree, required
• 3 years of relevant experience required
• Strong working relationships with executives in the clinical trial supply and pharmaceutical industries required.
• Experience contracting with and managing contract vendors.
• Strong working knowledge of investigational drug handling and distribution as well as the conducting and design of clinical trials.
• Strong organizational and communication skills required.
• Strong computer skills required.
• Ability to work in a fast paced, ever changing work environment.

Nice To Haves

• Doctorate, degree in pharmacy and Business administration background, preferably with an MBA preferred
• 15 + years’ experience in the pharmaceutical industry with strong working knowledge of FDA compliance, including cGMP and clinical supplies preferred.
• Minimum of 8 years proven leadership, supervisory and people management experience preferred.
• Licensed, or eligible for licensure, as a pharmacist in New York State preferred.

Responsibilities

• 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 to receive the bulk active and placebo product and oversee the secondary packaging, labeling and distribution of the product into interstate commerce.
• Responsible for forecasting drug supply needs throughout the duration of the clinical trial to ensure adequate quantities are available, and to avoid stock outs. In conjunction with the CHET Financial Leadership and CMSU Leadership, develop the CMSU operational budget and assist and managing to it. Assure revenues to maintain financial viability. Assist the coordination of CMSU’s monthly billing process. Responsible for identifying opportunities for cost savings and revenue enhancements. Responsible to ensure that the CMSU’s time and effort is accurately reported by project to the CHET finance team for billing to each project.
• Prepare budgets, background, rationale, CVs, bio sketches, experience tables/charts and other requested materials in support of grant submissions for internal and external clients. Work in close collaboration with the Quality Assurance Group. This 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. Compliance consulting to the University as requested will be provided.
• Responsible for ensuring regulatory compliance with investigational drug/device regulations and actively supporting IND submission for internal/external clients with focus on the Chemistry, Manufacturing and Control (CMC) section of the IND. Assist CMSU Leadership and the senior compliance officer responsible for FDA/State Board of Pharmacy regulations/audits.
• Other job duties and projects as assigned

What This Job Offers

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