Director Operations, CMSU

Rochester, NY

GENERAL PURPOSE:

This position directs, oversees and coordinates all aspects of the Clinical Material Services Unit (CMSU) related to clinical supply operations and clinical pharmacy information services. Ensures compliance with Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs) standards meeting the requirements of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (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 appropriate leadership to ensure appropriate 21 CRF part 11 technologies are maintained at the CMSU [e.g. ClinPro LBL, temperature monitoring, etc.). Liaises directly with internal and external sponsors. Serves as a resource for clinical pharmacy information as needed in support during the planning and implementation stages of clinical studies. Manages operations of as the ‘central pharmacy’ for National Institute of Health and other networks (e.g. NeuroNEXT, EPPIC-NET, Healey ALS Platform Trial and PrecISE). Ensure that the CMSU is well positioned to support remote/virtual clinical trials with direct-to-patient distribution of investigational products/devices.

RESPONSIBILITIES:

Responsible for all aspects of drug/device supply operations:

  • Works in collaboration with all applicable stakeholders in business development, project management, budgets, and financial activities relating to investigational and marketed product drug/device supplies, components, and comparator/supplemental products.

Directs 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. Ensures that resources and processes are in place to promptly respond to inquiries from site personnel. Ensures 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, ensures the set-up of these technologies for each study is appropriate to meet the needs of the given clinical trial supply requirements.

Management of CMSU Operations Personnel:

  • Recruits, trains, and supervises the Operations Group. Recommends or approves action on appointments, promotions, 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.

  • Works in collaboration with Executive Director and Project Manager to provide input and oversight in the creation of study-specific Clinical Material Specification Sheets (CMSS) and process orders (PO).

  • Responsible for ensuring 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). Takes the lead on all facility build-outs and upgrades. Works in close collaboration with URMC space management, contractors, etc., on all space-related projects. Ensures that all CMSU facilities comply with GMPs, and as new space is acquired, is responsible for all aspects of converting the space to GMP-compliant space as needed, including air handling systems, water, utilities, backup generators, security, etc.

  • Works in close collaboration with the Quality Assurance Group. This group oversees all operational aspects of GCP, GLP, and GMP associated with CMSU to comply with Federal, State, and ICH Regulations and other regulatory authorities as applicable. Compliance consulting with 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 a focus on the Chemistry, Manufacturing, and Control (CMC) section of the IND. Acts as the senior compliance officer responsible for FDA/State Board of Pharmacy regulations/audits. In the event that CMSU’s business strategy includes becoming registered with the FDA and/or the DEA, this position will be responsible for ensuring that all requirements for initial registration and ongoing registered status are satisfied.

  • Annually, in conjunction with the CHET Financial Controller, develops the CMSU operational budget and manages it. Assures revenues to maintain financial viability. Responsible for coordination of CMSU’s monthly billing process. Responsible for ensuring that the CMSU’s time and effort are accurately reported by the project to the CHET financial controller for billing to each project. Prepares budgets, background, rationale, CVs, bio sketches, experience tables/charts, and other requested materials in support of grant submissions for internal and external clients

  • Responsible for identifying opportunities for cost savings and revenue enhancements.

Other projects and job duties as assigned.

QUALIFICATIONS:

  • Requires a BS, or Doctorate, degree in pharmacy and Business administration background, preferably with an MBA required.

  • Minimum of 15 years of experience in the pharmaceutical industry with strong working knowledge of FDA compliance, including cGMP and clinical supplies required.

  • Minimum of 8 years of proven leadership experience required.

  • Strong working relationships with executives in the clinical trial supply and pharmaceutical industries required.

  • Experience contracting with and managing contract vendors required.

  • Strong working knowledge of investigational drug handling and distribution as well as the conducting of clinical trials required.

  • Strong organizational and communication skills required.

  • Strong computer skills required.

  • Licensed, or eligible for licensure, as a pharmacist in New York State required.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $84,700 - $127,100 Annually

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.

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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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