The NIH Clinical Center is the largest hospital in the world totally dedicated to translational clinical research. The hospital maintains a 200-bed capacity that supports the intramural research programs of Institutes and Centers across the NIH. The hospital supports an extensive range of research participants who are patients with long-standing relationships with their Institute’s care team. As a clinical hospital department chief, the incumbent will lead a department of about 128 staff members (including 25 radiologists and nuclear medicine physicians) in a complex clinical research setting.
Currently, there are about 1,600 clinical research studies in progress at the NIH Clinical Center. About half are studies of the natural history of disease, especially rare diseases, which often are not studied anywhere else. Most other studies are clinical trials, which often are the first tests of new drugs and therapies in patients. The clinical trials at the NIH Clinical Center are predominantly Phase I and Phase II, often first-in-human to test safety and efficacy.
This position is located in the Office of Research Support and Compliance. This Office is responsible for ensuring the quality and integrity of the research conducted at the NIH including overseeing compliance with the regulations/guidelines that govern clinical research, basic research, manufacturing of cellular therapeutics, radioligands and pharmacy products. To carry out this overall responsibility, the Office works in conjunction with various CC and NIH departments in areas such as research integrity, and human subject’s protection. The Office provides oversight and support for the various GMP and USP facilities located within the NIH Intramural Research Program. In addition, the Office develops regulatory strategies to determine Clinical Center and NIH’s needs and ensures timely approval of all submissions. The Office reviews all submissions prior to their submission to various committees, regulatory bodies and NIH leadership; performs and manages submitted data and provides independent analyses ensuring that quality standards are met and submissions meet deadlines; reviews regulations and guidance documents that govern research and manufacturing activities and provides summary statements to CC and NIH leadership and investigators and provides input concerning CC and NIH policies, practices and systems. To carry out its mission, the Office interacts and liaisons with regulatory bodies, accrediting associations and NIH Leadership to include planning, training and overseeing such interactions. The Research Regulatory Affairs—Facilities Section within ORSC provides regulatory support for the various cGMP and compounding facilities on campus. Support includes guidance in meeting the regulatory requirements with regards to facility design and facility operations. The section will maintain centralized resource contracts such as for specialized cleaning and preventative maintenance, will aid in FDA Inspections of facilities, aide in development of Quality Systems, and responses to audits. The QA Specialists in the section will conduct routine audits, support the Environmental Monitory Advisory Committee and the Change Control Board and track/trend. data.
We seek an individual who possesses exceptional communication skills, and a high level of expertise leading, consulting and advising a diverse workforce. The ability to partner and provide sound guidance at all levels within a complex aseptic processing setting is key in the performance of duties associated with this position.
Candidates must be experienced and has direct responsibility using knowledge of regulatory statutes and guidance for the oversight and monitoring of NIH research facilities to ensure compliance with pertinent regulations, applicable policies, standards and procedures as well as with state of the art methods using sound scientific principles as they apply to regulated cleaning services, pest management, regulatory required environmental monitoring, qualification and management of manufacturing materials and hospital supplies. Using regulatory knowledge of the requirements for cGMP and compounding facilities; selects, qualifies and oversees the specialty contracts for cleaning services, pest management, environmental monitoring (to include identification of specific disinfectants based on the microbial results from monitoring), materials management and vendor qualifications for suppliers.
The ideal candidates should possess: a bachelors degree in the health sciences with 10 years experience in aseptic processing facility and demonstrated experience managing quality systems. Comprehensive knowledge of and ability to interpret and apply the regulatory knowledges of USP (sterile compounding), USP (non sterile compounding, USP (PET radioligands), 21 CFR 211 (cGMP), 21 CFR 212 (cGMP radioligands), 21 CFR 312 (Investigational New Drugs), 21 CFR 812 (Investigational Device Exemptions),21 CFR 1271 (Cellular and Biologicals), FDA guidance on 503A and 503B facilities (sterile compounding), FDA guidance on cell therapy products not covered by 21 CFR 1271, and ISO standards.
Additional Salary Information: Salary will be commensurate with experience and accomplishments. A full Civil Service package of benefits (including retirement, health, life and long-term care insurance, Thrift Savings Plan, etc.) is available. Applications must be submitted via the www.usajobs.gov website by searching for announcement number: NIH-CC-DE-10270130. Applications can be submitted from August 22, 2018 to August 31, 2018. Please include in your CV a description of mentoring and outreach activities in which you have been involved, especially those involving persons from groups which are underrepresented in biomedical research. If you have questions about this position, please contact Lakisha Harris at (202) 691-2113 or Lakisha.firstname.lastname@example.org. This position is subject to a background investigation.
Internal Number: NIH-CC-DE-10270130
About National Institues of Health
The National Institutes of Health Clinical Center, America's research hospital, is located on the NIH campus in Bethesda, Md. Through clinical research, clinician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation's health.
The Clinical Center marked its 60th anniversary in July 2013 and dedicated its new hospital, the Mark O. Hatfield Clinical Research Center, in 2004. In 2011, the Clinical Center received the Lasker-Bloomberg Public Service Award given by the Albert and Mary Lasker Foundation. The award honors the CC for serving since its inception as a model research hospital.