*Description:*
*COMPANY INFORMATION*
Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
For more information about Leidos Biomedical Research Inc., please visit our webpage at www.leidosbiomed.com.
*PROGRAM DESCRIPTION*
Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.
*JOB DESCRIPTION*
The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical support to the NIAID Division of Clinical Research (DCR) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. In support of the viral hemorrhagic fevers (VHF) initiative, DCR has requested Leidos Biomed to provide support for the emergent global Ebola Virus Disease.
The Clinical Project Manager IV will: 1) provide essential project management expertise to support the comprehensive technical work scope of the Ebola response program, 2) serve as a team-oriented leader utilizing both executive skills and project management expertise, 3) plan, organize, execute, assess and report on program objectives, 4) coordinate, direct and review work of other Clinical Project Managers, 5) be responsible for the conduct of project management operations supporting the Ebola project, including: identification of critical paths, resource restrictions and other risks, issue logs, decision points, and project milestones, 6) develop project templates and processes using project management tools to optimize PMO performance, 7) monitor progress against plans and the status of key deliverables, 8) and develop and implement a research quality system consisting of policies, standards, documentation and training methods.
*Qualifications:*
*BASIC QUALIFICATIONS*
* Possession of a Doctorate degree from an accredited college/university in a field related to clinical research/project management or eight (8) years related experience in lieu of degree
* Foreign degrees must be evaluated for U.S. equivalency
* A minimum of ten (10) years of progressively responsible and responsive experience, achievement and organizational visibility in project management, including at least eight (8) years directly managing multiple concurrent clinical trial projects
* At least three (3) years of experience managing a team of project managers
* Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners, within reasonable budgetary restrictions, and in compliance with deadlines and regulatory and client requirements
* Ability to work in a clinical setting both independently and within a team of technical specialists and project leaders
* Ability to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risks
* Excellent communication skills with the ability to develop project management staff
* Ability to judge, organize, prioritize and assign multiple tasks/projects with simultaneous orientation to detail and vision to understand the high-level interrelationships between the organization and the client
* Project Management Professional (PMP) certification
*PREFERRED QUALIFICATIONS*
* Clinical research project management experience
* Familiarity with regulatory processes/strategies, operational and/or product quality management and clinical trials management
*Leidos Overview:*
Leidos is an applied solutions company focused on markets that are seeing converging business and technological trends, and address basic, enduring human needs: defense and national security, health and life sciences, and energy, engineering and infrastructure. The Company's approximately 20,000 employees serve customers in the U.S. Department of Defense, the intelligence community, the U.S. Department of Homeland Security, other U.S. Government civil agencies and commercial health and engineering markets. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos is an Equal Opportunity Employer.