The Henry M. Jackson Foundation
Bethesda, MD 20817
The Henry M. Jackson Foundation (HJF) is seeking a Medical Officer to support the Division of Acquired Immunodeficiency Syndrome (DAIDS) of National Institute of Allergy and Infectious Diseases (NIAID) as part of the HJF-DAIDS Program., located on Rockledge Drive in Bethesda, Maryland. HJF provides administrative and management support to DAIDS.
DAIDS was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Specifically, the mission of DAIDS is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), supporting the development of therapies for HIV infection and its complications and co-infections, and supporting the development of vaccines and other prevention strategies.
The incumbent will be responsible for managing HIV vaccine and to a lesser degree tuberculosis vaccine clinical research to be conducted in the NIAID-funded DAIDS clinical research networks and non-network clinical studies. Responsibilities include assisting DAIDS in the preparation of clinical trial protocols; the preparation of Investigational New Drug (IND) and other communications with the FDA; and in ensuring clinical trial patient safety and protection.
1. Participates in the review, planning and implementation of clinical trials for HIV vaccines and less frequently for adult TB vaccines including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements and identifying medical and logistical problems that may impede the study. Advises DAIDS program management of the merits and deficiencies in the proposed study.
2. Provides subject matter expertise during protocol development leading to protocol review at the Prevention Sciences Review Committee meetings. Ensures that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner leading to Medical Officer approval, which then allows the DAIDS Pharmaceutical Affairs Branch (PAB) and Regulatory Affairs Branch (RAB) to authorize protocol initiation.
3. Provides clinical expertise to assist in developing IND applications Individuals providing this expertise will be named as the reviewer of information relevant to the safety of the drug in question, on line 15 of the IND application (FDA Form 1571). Evaluates annual IND reports for medical safety and report findings to PAB and RAB.
4. Provides medical expertise during protocol follow-up stages for monitoring subject safety, reporting of safety events, and making recommendations to help ensure subject protection, reliability of endpoint data, and study integrity and success.
5. Previews serious adverse events (SAE) reporting, provides expert medical advice for potential impact of SAEs in ongoing research and participate in the preparation of reports submitted to the FDA.
6. Provides clinical and scientific information for preparing NIAID communications to the FDA, other government and non-government agencies, pharmaceutical companies, and Data Safety Monitoring Boards.
7. Makes site visits when necessary to obtain additional data and information for use, by Federal staff, in consideration and evaluation of ongoing and future programs.
8. Attends and participates in national/international scientific meetings/conferences, national meetings of professional societies and organizations in order to meet with clinical network investigators and provide subject matter expertise; attends NIAID-funded clinical network steering committee meetings; participates as a medical expert in protocol development gatherings; presents network information as appropriate.
9. Works in a collaborative manner with other medical officers in the Vaccine Clinical Research Branch (VCRB), in particular by providing consultative infectious disease and/or epidemiologic expertise and providing cross-coverage for other medical officers’ studies as needed.
10. Completes assigned HJF-DAIDS’ tasks, including submission of status reports and attendance at meetings.
11. Prepares scientific papers for presentation at local and national meetings and for publication in medical and scientific periodicals.
12. Performs other assignments as required.
Required Knowledge, Skills, and Abilities: M.D. with extensive clinical care experience, clinical trial and research experience in infectious diseases and related disciplines such as other immunologically related diseases. Knowledge of NIH extramural activities related to clinical studies of HIV/AIDS. Experience in medical review of adverse events associated with clinical trials. This expertise is needed to support Expedited Adverse Event (EAE) reporting and safety management and implementation. Excellent written and oral English communication skills sufficient to independently develop and provide training or presentations to groups. Communicating in written English without editing required.
Minimum Education/Training Requirements: M.D. degree.
Minimum Experience: 6 or more years of related experience.
Physical Capabilities: Bending, standing, and sitting.
Required Licenses, Certification or Registration: Board certified or Board eligible preferred in internal medicine, pediatrics, infectious diseases, epidemiology, or other related area. If medical degree is from outside the U.S., ECFMG certificate plus extensive experience.
Work Environment: Office environment.
It is a condition of employment with HJF-DAIDS that contractors undergo a favorable National Agency Check and Inquiry Investigation plus a Credit Check (NACIC), a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).
Please apply on-line at www.hjf.org/careers/open-jobs Click “Advanced Search” to enter job number 207339 in the Job Opening ID box.
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. is a congressionally authorized, not-for-profit corporation that provides unparalleled scientific and management services to military medical research and education programs worldwide. Our mission is to advance military medical research. AA/EEO
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