Biobank IT Lead (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 IT Director. 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.
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. 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 populations 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 IT Director will lead the effort to build and integrate systems to support the Cancer Moonshot℠ Biobank, leading to a state-of-the-art infrastructure to support the engagement of patients and physicians, 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.
Responsibilities include, but are not limited to:
- Develop the architecture to support patient consent and enrollment, clinical and specimen processing data capture, patient and physician engagement portal, analysis platform, biospecimen processing core, specimen catalog, online centralized consent, and the system for online return of test results
- Work closely with the Leidos Biomed Cancer Moonshot℠ Biobank Program Manager to lead the Leidos Biomed IT team in conjunction with the Molecular Pathologist and Biospecimen Source Site (BSS) lead to build the infrastructure needed to collect and process the specimens and data required by the Moonshot℠ Biobank program
- Work closely with key NCI stakeholders to ensure the systems being selected and developed will meet the project needs and provide the best value for NCI
- Work closely with members of Leidos Biomed IT across the organization to harmonize and integrate elements of the infrastructure
- Manage a Requirement Analyst to ensure the scientific requirements being gathered are traceable and testable
- Interpret and document NCI’s requirements and expectations regarding infrastructure to support biospecimen collection, biobanking, and distribution
- Ensure security requirements for the IT infrastructure supporting this program are met. Specifically, ensure that the systems storing and processing federal data conform to the Federal Information Security Management Act of 2002 (FISMA) and National Institute of Standards and Technology (NIST) 800-53 rev 4. Must be familiar with security controls required for a FIPS-199 FISMA moderate system
- Plan for the integration of systems and data with the NCI’s Genomic Data Commons efforts
- Develop and implement project management standard operating procedures based on Project Management Institute (PMI) best practices and the U.S. Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC)
- Plan, develop, and maintain tracking and communication of project milestones, risks, issues, and schedule-related concerns.
- Provide project assessment reports to the program manager when needed
- Work in collaboration with the government customer to clear pathways for project requirements, develop requests-for-proposal documents to source potential performers, review vendor proposals, and manage project execution of the subcontractors
- Attend meetings with the customer in the development and tracking of realistic technical milestones for project execution
- Work with existing Leidos Biomed development teams and technical project managers to monitor project deliverables and timelines and provide scientific evaluation of supporting technical data to ensure product quality objectives and project deadlines. May serve in the role of technical project manager for key subcontracts
- Work with the project manager and finance team to ensure the budget estimates for the projected IT expenditures are as accurate as possible
- Write, review, and evaluate Standard Operating Procedures supporting program objectives
- Supervise staff of up to five personnel
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a PhD from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, a minimum of eight (8) years progressively responsible job-related experience involving IT in the life sciences, and/or technical project management that includes managing IT projects in support of Federal Government contracts
- Experience in the agile software development process
- Ability to lead teams through the requirement development phase of multiple new systems, as well as through integration of existing systems to form a new infrastructure
- Possess excellent written and oral communication
- Knowledge of clinical systems involved in the collection and handling of clinical data, including Personally Identifiable Information (PII) and Health Insurance Portability and Accountability Act (HIPAA) considerations
- Ability to rigorously evaluate technical information, excluding hands-on IT, sysadmin, or development work
- Ability to communicate effectively, orally, and in writing with non-technical and technical staff at various levels of the organization, including independently interfacing with government customers, Leidos Biomed Biospecimen Science experts, and project teams
- The candidate must be familiar with modern software development and deployment tools and techniques. These include Java, Tomcat, apache (including mod_security and mod_evasive), Python, Ruby on Rails, MongoDB, Amazon AWS, EC2, S3, RDS, Angular JS, and other such frameworks. Oracle is also preferred. Familiarity with DevOps and security tools such as GitHub, Travis, Jenkins, Cucumber, Behave, Docker, Loggly, Nessus, and Appscan are also preferred. F5 BigIP understanding may also be a requirement.
- Must be proficient in Microsoft Project in addition to the Microsoft Office Suite
- Ability to oversee and supervise staff of up to five
- Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Knowledge of infrastructure used to support clinical trials or clinical studies processes and procedures
- Knowledge of FISMA requirements. Specifically, ensure that systems storing and processing federal data conform to FISMA and NIST 800-53 rev 4. Must be familiar with security controls required for a FIPS-199 FISMA moderate system
- Experience with the Agile software development life cycle, Agile, Scrum, Kanban, and how to fit those into the waterfall environment of EPLC
- Knowledge of biobanking systems involved in patient specimen collection and handling
- Thorough understanding of security systems and measures used in medical research to protect the privacy and identity of research participants