Biobank Program Manager (NCI)
The Leidos Biomedical Research, Inc.’s, staff of scientific, technical, and support professionals conduct basic and applied research in cancer and AIDS. It operates and manages the federal government’s only vaccine manufacturing facilities (Vaccine Pilot Plant [VPP] and Biopharmaceutical Development Program [BDP]) and runs the high-performance Advanced Biomedical Computing Center. It also operates the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center focused on cancer and AIDS research.
The Leidos Biomedical Research Group’s Biospecimen Research Group (BRG) supports projects across the National Cancer Institute (NCI) that require expertise in the infrastructure needed to support the collection and use of human biospecimens for cancer research as well as other areas where scientific knowledge of advanced computing and/or scientific technologies is required.
The NCI’s Biorepositories and Biospecimen Research Branch (BBRB) and the Leidos Biomed BRG are jointly responsible for developing a common biorepository infrastructure that promotes resource sharing and team science, to facilitate multi-institutional, high-throughput genomic and proteomic studies. Currently, Leidos Biomed is supporting the NCI Cancer Moonshot℠ Biobank program. The NCI’s Cancer Moonshot℠ program is intended to accelerate cancer research in key strategic areas. The strategic areas were deliberated and identified by experts in the cancer research community convened in 2016 through a “Blue Ribbon Panel” (BRP). The BRP produced a set of recommendations that are now publicly available (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel). The strategic areas addressed in the BRP recommendations have in common two core elements: (1) critical scientific and medical questions, the answers to which could rapidly accelerate progress in cancer research, and (2) the need for nationwide participation by a diverse group of research participants who have agreed to share their biospecimens and/or derived data to contribute to progress in cancer research. The latter element, an engaged and diverse research participant population and their donations of biospecimens and data, will be critical to accelerating research progress and is the subject of the project for which Leidos Biomed is seeking an experienced Program Manager. The Cancer Moonshot℠ Biobank will provide a networked biospecimen resource that will serve the goal of the Cancer Moonshot℠ to accelerate research progress in cancer.
For the Moonshot℠ Biobank Program, up to 2,000 longitudinal cases from patients with 10 different cancer types will be collected, to include tissue resections, core biopsies, fine needle aspirates, and blood. The biospecimens will be utilized by researchers studying the mechanisms of drug resistance and sensitivity and other important cancer research questions. Subcontracts with up to 100 different cancer centers will be put in place to enable the engagement and participation of physicians and patients, including minority and underserved as well as adolescent and young adult cancer patients. Tumor molecular characterization tests will be performed as part of the program to help inform patient treatment decisions. Some tissues will be sent for Patient Derived Xenograft (PDX) model development at the Frederick National Laboratory for Cancer Research. A central Biospecimen Core Resource will be engaged for biospecimen processing and storage. Project data will be uploaded to the NCI Genomic Data Commons to enable data analysis by the broader research community.
The Biobank Program Manager will lead the Leidos Biomed team, in conjunction with NCI, to develop a network of community cancer centers as well as other Biobanks and medical centers to engage physicians and patients in joining the Cancer Moonshot℠ Biobank to advance scientific research for cancer prevention and treatment:
- Lead the Leidos Biomed team in conjunction with the IT Director, Molecular Pathologist, and Biospecimen Source Site (BSS) lead, to build the infrastructure needed to collect and process the specimens and data being required by the Moonshot℠ Biobank program
- Work directly with the NCI Biorepository and Biospecimen Research Branch (BBRB) program staff to document key collection and accrual requirements and ensure that they are being documented in the protocol and implemented appropriately at Leidos Biomed
- Communicate the program’s progress against key milestones, assess and report risks and mitigation strategies, work with the Leidos Biomed financial team and other members of the Leidos Biomed team to ensure the budget is being appropriately managed. Report directly to the Director of the Biospecimen Research Group. Accept redirection from the Director of Quality for required project metrics, audits, etc.
- Manage the BSS Lead Manager, the Biospecimen Core Repository Technical Project Manager, and the project support staff
- Meet requirements from the Project Management Office (PMO) for scheduled updates, including risk factors and finances
- Provide regular written reports detailing progress against tasks and milestones
- Work with key leads to ensure the operational needs of the project are being met
- Maintain oversight of the scientific protocols to be used to guide the project workflow
- Work with the Director of IT to ensure data from the program are reaching the appropriate repositories and are collected utilizing the desired standards. The Cancer Moonshot℠ Biobank IT solution itself will lead to a state-of-the-art infrastructure to support the engagement of patients and physicians, including centralized online consent, the collection of key clinical and specimen processing data, assay data, return of test results to the physician/patient, and development of a catalog for distribution of specimens
- Understand the repositories used to collect and manage the data associated with projects, as well as contribute to their design when needed
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a PhD degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a biomedical science related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
- In addition to education requirements, eight (8) years of professional project management experience in biotech, pharma, or government using standard project management tools and techniques
- Ability to manage customer expectations, meet the customer’s needs, and manage a schedule
- Strong writing skills, including ability to review the writing of others and provide constructive feedback
- Ability to travel up to 20% during the first two years may be required
- Experience managing direct reports
- Must be able to obtain and maintain security clearance
Candidates with these desired skills will be given preferential consideration:
- Experience managing a large network of specimen collection activities
- Experience in the ethical, legal, and regulatory aspects of biobanking and human subjects research
- Knowledge of best practices in biobanking operations and biobanking data standards
- Experience in biospecimen sciences research with knowledge of pre-analytical influence
- Demonstrated, excellent written and verbal communication skills, including formal presentation skills, to be applied in reporting on project progress to senior NCI and Leidos Biomed leaders and in engaging the support of leaders at program-supported medical institutions
- Understanding of the IT that may need to be operationalized for the program
- Experience developing or directing a biobank