Leidos Sr. IND Manager (NCI) in BETHESDA, Maryland
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.
The Clinical Monitoring Research Program (CMRP) provides regulatory and project management coordination associated with the clinical development and conduct of clinical trials in support to the Surgery Branch, Office of Protocol Support, Center for Cancer Research (CCR), National Cancer Institute (NCI).
JOB DESCRIPTION/BASIC FUNCTION
The Sr. IND Manager:
Oversees and directs all regulatory activities for clinical protocols and associated documents to ensure alignment and compliance with regulations and guidelines as well as with company policies
Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical protocols and associated documents.
Provides counsel to and manages the regulatory team
Ensures timely preparation of organized and scientifically valid applications.
Provides expertise in translating regulatory requirements into practical, workable plans.
Interacts with regulatory agencies
Selects, develops and evaluates personnel to ensure the efficient operations of the function
Assists in the collection and review of study-specific documentation for each protocol submitted under an IND
Compiles and maintains IND Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship
Coordinates activities pertaining to the compilation and submission of original INDs for management and multi-disciplinary team review
Provides technical expertise for the development of regulatory strategies in the preparation, submission, and approval of IND documents/submissions to the FDA, as described in 21 CFR 312
Requests, compiles, reviews and submits documentation for amendments, supplements, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs, IDEs and MFs for management review
Participates in the review and revision of standard operating procedures to adhere to FDA regulations and GCP guidelines
Monitors key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens
Serves as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance, review and expertise to ensure documentation conforms to applicable regulations and guidelines
This position is located in Bethesda, Maryland
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Possession of a Bachelor's degree from an accredited college/ university according to the Council for Higher Education Accreditation (CHEA) in a health/scientific, or medical related field or four (4) years related experience in lieu of degree
Master’s degree preferred
Foreign degrees must be evaluated for U.S. equivalency
A minimum of ten (10) years of progressively responsible regulatory experience
Knowledge of clinical trial fieldwork concepts and practices
Well versed in FDA regulations, 21 CFR, and GCPs
Knowledge of clinical research project implementation, with an understanding of project management, CRF and data collection/requirements, regulatory and quality assurance procedures and ICH guidelines
Working knowledge of scientific principles
Exercise good judgment in planning and accomplishing goals
Detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects
Demonstrated excellent written and verbal communication skills
Candidates with these desired skills will be given preferential consideration:
Knowledge of ICH guidelines
Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos is an Equal Opportunity Employer.