University of Rochester Director of Clinical and Business Affairs - Clinical Materials Services Unit (CMSU) - 224000 in Rochester, New York
Director of Clinical and Business Affairs - Clinical Materials Services Unit (CMSU)
School of Medicine & Dentistry
Full Time 40 hours Grade 057 Neuro-Ctr Health & Tech/CMSU
8 AM-5 PM; OCC WKND
To direct, oversee and coordinate all aspects of the Clinical Material Services Unit (CMSU) related to clinical supply operations, finance/administration, project management, business development 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. Simultaneously, ensure: continued growth of CMSU business via the management of the business development activities, including proposal development and project budget/contract negotiations; overall responsibility for creation and management of CMSU’s operational budget and profit and loss statement; time and effort reporting and monthly billing to each project account. Collaborate closely with the Director of Regulatory and Technology Affairs 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. Function is the lead for CMSU’s involvement as the ‘central pharmacy’ with NIH and other networks (e.g. NeuroNEXT, EPPIC-NET, Healy 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.
Responsible for all aspects of drug/device supply operations, business development, project management, budgets and finances relating to investigational and marketed product drug/device supplies, components and comparator/supplemental products as follows:
Direct the Clinical Supplies Operations Group within the CMSU : 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. Oversight of creation of study specific Clinical Material Specification Sheets (CMSS) and process orders. Ensure that resources and processes are in place to promptly respond to inquiries from site personnel. Provide training and direct supervision to the Project Manager Clinical Supply Operations.
Direct Business Development Activities within the CMSU : Respond promptly to requests for proposal from internal and external entities (e.g. academic institutions, NIH networks, individual investigators, CRO’s and biotech/pharma companies). All proposals will be tracked and general trends for wins/losses will be reviewed at least quarterly along with the overall strategic plan for all business development (BD) activities. Annually, determine which, if any, trade shows CMSU will exhibit at and which ones CMSU will have exposure to via attendance by BD. Continue to update the CMSU budget proposal algorithm and proposal template as deemed necessary. In conjunction with the BD team members and in collaboration with both internal university resources as well as new external collaborators, will generate proposals for internal and external clients. Establish relationships with and market services to potential customers. Lead kick-off meetings on newly awarded projects. Assign a Project Manager (PM) to each new awarded project and provide needed background information to get PM fully operational at the time of project hand off from BD to Operations.
Work in close collaboration with the Quality Assurance Compliance 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.
Work in close collaboration with the Regulatory Affairs/Facilities and Technology Management Group: This group is 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. Ensure that CMSU facilities are in compliance with cGMPs and as new space is acquired, responsible for all aspects of converting the space to cGMP compliant space as needed, including air handling systems, water, utilities, backup generators, security etc. This Group will continue to evaluate, implement, validate, manage and train on other 21 CRF part 11 compliant technologies that will streamline CMSU activities (e.g., Interactive Response System (IRS)/Interactive Web Response System (IWRS).
Management of CMSU Team
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.
Annually, in conjunction with the CHET Financial Controller, develop the CMSU operational budget and manage to it. Assure revenues to maintain financial viability. (5%)
Prepare 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 coordination of CMSU’s quarterly billing process; identifying opportunities for cost savings and revenue enhancements; and ensuring that the CMSU’s time and effort is accurately reported by project to the CHET financial controller for billing to each project. Act as senior compliance officer responsible for FDA/State Board of Pharmacy regulations/audits.
Other projects and job duties as needed.
Master’s degree in Business Administration; Bachelor’s or Doctorate degree in Pharmacy, and or relevant field. Minimum requirements include Master's degree in Business Administration or equivalent graduate training or experience in a specialty suited to the assignment; at least 8 years relevant work experience including substantial work at a leadership level, in similar organizations; equivalent combination of education and experience.
15 + years’ experience in the pharmaceutical industry with strong working knowledge of FDA compliance, including cGMP and clinical supplies strongly preferred.
Licensed, or eligible for licensure, as a Pharmacist in New York State.
Strong working relationships with executives in the clinical trial supply and pharmaceutical industries.
Experience contracting with and managing contract vendors.
Strong working knowledge of investigational drug handling and distribution as well as the conducting of clinical trials.
Strong organizational, presentation and communication skills, including written communications.
Strong computer and technical skills; problem solving and analytical skills.
Proven, effective strategic planning, analytical problem solving / decision-making, and leadership skills.
Ability to model leadership skills of professionalism, positive attitude, team building, good judgment and respect.
Ability to organize and prioritize work and perform several tasks simultaneously to meet deadlines and work effectively with people at all levels of the organization is essential.
Must be able to make effective decisions and be highly detail oriented.
Ability to productively manage several priority projects simultaneously.
Strong capacity for participating and collaborating within a team.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled