The Biorepository and Laboratory Services (BLS) Program Director leads an integrated biospecimen core program within the University of Minnesota’s Clinical and Translational Science Institute (CTSI). This encompasses oversight and expansion of BioNet, the University’s Biological Materials Procurement Network, as well as further development and oversight of new activities of the Biorepository and Laboratory Services (BLS) branch of CTSI. This position has accountability for all BLS divisions (BioNet, Laboratory Network, Biorepository Facility, Histology & Research Laboratory, and Digital Imaging). The BLS Program Director provides strategic and operational leadership for all aspects of this service working closely with the Director and Associate Director of Clinical Translational Research Services (CTRS), and the BLS Medical Director. BLS serves Investigators across the institution and related collaborators and the Program Director will work closely with clinical partners to ensure effective and compliant BLS services.
Essential Functions or Job Duties:
(50%) In collaboration with CTRS Leadership and the BLS Medical Director, plan, develop, implement, and manage BLS operations and programs, including strategic planning (set goals, prioritize, and maintain alignment with organizational objectives): • Provide oversight of administration, operations, staffing, equipment/infrastructure, and guidance about the expansion of BLS. • Develop and maintain a viable business plan to support both an Internal Service Organization (ISO) model, as well as external sales, taking into account the existing constraints and open possibilities. • Manage the BLS budget to include: working with finance staff to ensure strong fiscal processes, practices, and transactions; ensuring strong and balanced internal and external sales; and collaborating with CTSI leadership to establish appropriate rate structures. • Establish and co-chair a BLS Advisory Committee to develop programmatic goals and strategy, prioritize specimen procurements of strategic importance, and develop policies for specimen distribution in support of research. • Manage prospective collections for the BLS Biorepository in types of specimens currently underrepresented in the archives, and in the areas of strategic importance for UMN researchers and M Health Fairview • Ensure the technical parameters, procedures and methods of the collections satisfy current needs for downstream applications including, but not limited to, molecular genomics methods, so as to include relevant germline genetic material for future comparisons. As well, modify BLS practices for best outcomes in histology and immunohistochemistry on both formalin-fixed paraffin embedded and fresh frozen tissues. Develop new techniques as appropriate to support novel research community needs. • Manage the BLS Repository facility located at 1200 Washington Avenue SE, Minneapolis. • Ensure smooth operation of freezers and liquid nitrogen containers. • Work with staff from the University’s Advanced Research and Diagnostic Laboratory (ARDL) to ensure daily operation in the shared facilities. • Ensure practical use and continued growth of the BLS specimen database software. • Ensure utilization of the archived specimens stored within the BLS Biorepository. • Oversee the BLS Histology & Research Laboratory to increase the utilization of this facility by the research community. This would be achieved by: o Expand the scope of techniques offered by the histology lab to satisfy unmet needs and challenges faced by researchers. o Ensure all researchers at the University utilizing immunohistochemistry (IHC) and histology are familiar with the BLS core facility and its offerings. Written and oral presentations to educate the research community about BLS capabilities will be required periodically. • Provide direction for emerging BLS service areas, such as specimen processing/lab testing and digital pathology imaging.
(10%) Ensure all local and federal regulatory requirements are followed: • As Principal Investigator for BLS, maintain Institutional Review Board (IRB) approval. • Participate in IRB ancillary reviews on behalf of BLS; coordinate or cede responsibility with Fairview Research Administration (FRA) for these reviews. • Ensure regulatory compliance and safety of BLS operations. • Work with the IRB, FRA, CTSI leadership, and other involved parties to ensure regulatory compliance, in particular to facilitate effective and prospective patient consent for research use of stored samples. • Maintain regulatory compliance and work towards fulfilling ISBER and CAP standards for biorepositories.
(10%) Collaborate with investigators, project managers, and other staff; both within and outside U of MN: • Maintain a positive research support culture within BLS, recognizing importance of support for academic medicine and health science research. • Expand working relationships with CTSI’s Biomedical Informatics core for specimen-data integrations. • Exchange ideas and experiences with similar biorepositories at other academic institutions. • Expand working relationships with other units facilitating research at the University of Minnesota both within CTSI and outside of CTSI, including, but not limited to: ARDL, M Health Clinical Research Unit, Cancer Center Translational Therapy Lab, Lab Medicine and Pathology, Genomics Center, University Imaging Centers, Flow Cytometry, Center for Mass Spectrometry and Proteomics, Research Animal Resources, Anatomy Bequest Program, and others. • Ensure a professional and researcher-friendly atmosphere, offering help to prospective BLS customers.
(10%) Recruit and successfully activate BLS projects: • Serve as point of contact for all BLS matters. • Actively seek internal customers from the University of Minnesota system interested in utilizing the BLS facilities. • Prepare call for proposals to offer small-scale demonstration of the capabilities of BLS to successful applicants, awarded on a competitive basis. • Proactively work with researchers to include BLS in their research plans and include BLS services in the proposal at the time of grant submission. • Offer support to active research programs requiring prospective collections of specimens from human subjects. • Work with researchers from within and outside of the University to satisfy the needs of their research project(s) within the scope of activity and solicit requests for potential extension of BLS capabilities. • Reach out to external customers from the broad scope of the biomedical industry in order to improve utilization of BLS services. • Increase awareness of BLS with the University community by collaborating with CTSI’s communications manager to use tools and resources of CTSI, and existing opportunities such as vendor shows.
(20%) Manage and develop BLS staff by forecasting staffing needs, hiring and training staff, and managing workloads and project timelines: • Manage daily operations of all BLS divisions (BioNet, Laboratory Network, Biorepository Facility, Histology & Research Laboratory, and Digital Imaging). • Forecast staffing needs, including on-call procurement staff, to meet needs across all BLS service areas. • Manage hiring and training for all BLS staff. • Supervision of all BLS staff. • Ensure coverage of biospecimen procurement operations in the current 3 main geographic locations: UMMC East Bank, UMMC West Bank and the M Health Clinics and Surgery Center, as well as possible future expansion to include other sites.
All required qualifications must be documented on application materials.
Required Qualifications: • BA/BS with a strong background in biological sciences or business with at least 8 years of experience or an advanced degree with 6 years of experience and prior oversight of a small department or cross-disciplinary team. • Specialized knowledge and/or experience in the areas of biobanking and its regulatory milieu. • Effective communication skills and ability to work with broad range of customers, including academic and external customers. • Personal characteristics: enthusiasm for the mission of support for biomedical research at the U of M, good communication skills, proven record of accomplishment of assigned goals.
Preferred Qualifications: • Professional Certification in related area. • Master’s degree in biological sciences or business. • Familiarity with workflow of operations in pathology and in biomedical research • Tolerance for ambiguity and ability to manage in a changing environment.
Internal Number: 335495
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.