The Henry M. Jackson Foundation
HJF is seeking a Medical Officer to provide support under the an NIH-funded contract to the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH, located on Rockledge Drive in Bethesda, Maryland. Under the NIH Contract, HJF’s seperate operating division, HJF-DAIDS, provides scientific and operations support to DAIDS including the Therapeutics Research Program.
The incumbent will provide clinical research support to the of as part of the HJF-DAIDS Program. Responsible for assisting DAIDS in the preparation of clinical trial protocols; the preparation of Investigational New Drug (IND) and other communications with the Federal Drug Administration (FDA) and in ensuring clinical trial patient safety and protection. This position is with the HIV Research Branch of the Therapeutics Research Program.
1. Participate in the review, planning and implementation of therapeutic HIV clinical trials including evaluating: hypothesis, objectives, study design, feasibility, regulatory requirements and identifying medical and logistical problems that may impede the study. Advise DAIDS program management of the merits and deficiencies in proposed studies.
2. Provide subject matter expertise during protocol development leading to Clinical Sciences Review Committee (CSRC) review. Ensure that concerns raised during review are addressed by the Protocol Development Team in a timely manner leading to Medical Officer approval allowing for authorization of protocol initiation by the DAIDS Pharmaceutical Affairs Branch (PAB) and Regulatory Affairs Branch (RAB).
3. Provide clinical expertise to assist in developing Investigational New Drug (IND) applications (Note: Incumbent’s name will appear on line 15 of the IND application (FDA Form 1571) as responsible for review and evaluation of the drug’s safety). Evaluate annual IND reports for medical safety and report findings to PAB and RAB.
4. Provide medical expertise in protocol follow up stages in the areas of subject safety and protection, reliability of study endpoint data. Make appropriate recommendations to DAIDS to ensure trials are conducted according to protocol.
5. Provide clinical and scientific expertise to assist NIAID to prepare communications with the FDA, other government and non government agencies, pharmaceutical companies, Data Safety Monitoring Boards and other stakeholders.
6. Make site visits when needed to obtain data and information to assist DAIDS in evaluating the site for ongoing and future programs.
7. Review serious adverse events (SAE) reports. Provide expert medical advice on the potential impact of SAEs on ongoing research. Sign-off on safety reports. Assist in the preparation of SAE reports submitted to the FDA.
8. Attend and participate in national/international scientific meetings/conferences, national meetings of professional societies and organization in order to meet clinical network investigators and provide subject matter expertise. Attend NIAID funded clinical network steering committee meetings. Participate as a medical expert in protocol development gatherings and present network information as appropriate.
9. Prepares scientific papers for presentation at local and national meetings and for publication in medical and scientific periodicals.
10. Complete assigned HJF-DAIDS’ tasks, including submission of status reports and attendance at meetings.
11. Performs other assignments as required.
Required Knowledge, Skills, and Abilities:
• Broad range of clinical care, clinical trial and research experience in Infectious Diseases or other immunologically related disease, experience in HIV/AIDS and its treatment desirable.
• Interest in translational research. Experience in laboratory-based or translational research a plus.
• Scientific, clinical and technical knowledge sufficient to work effectively toward the mission and activities of the work unit.
• Ability to think creatively, but also carry out daily operational tasks.
• Excellent verbal, written and interpersonal skills; the ability to communicate effectively with all levels of staff including doctoral level investigators, institute colleagues, other staff, non-governmental organizations and high level pharmaceutical company staff.
• Skill in written communication of scientific, technical or clinical information to both professional and lay personnel. Ability to independently make effective presentations, publish scientific, technical or clinical information and prepare materials for distribution with little or no editing.
• Experience in clinical trials research including protocol preparation and review and medical review and follow-up of adverse events associated with clinical trials.
• Experience in Microsoft Office (Word, Excel, PowerPoint) essential; experience with Microsoft Access, Microsoft Project desirable; knowledge of document management systems such as SharePoint or Live link desirable.
• Ability to learn and function in the context of federal and NIH Operations, policies and procedures.
• Ability to work independently, function effectively as part of a team, multi-task effectively and meet deadlines.
• Ability to independently research problems and issues, use discerning judgment in problem solving for organization, management and scientific issues using a significant degree of qualitative, quantitative and analytical skill.
• Project management experience and organizational skills, knowledge of, or willingness to learn, management techniques as applied to health sciences administration to effectively evaluate and respond to organizational needs.
Minimum Education/Training Requirements: M.D. degree. Board certified or Board eligible for certification in internal medicine, infectious diseases, clinical immunology or other related area.
Minimum Experience: 4-6 years of related experience. In addition, 1 year of research experience preferred.
Physical Capabilities: Bending, standing, and sitting.
Required Licenses, Certification or Registration: Licensure to practice medicine within the continental United States. Board certified or board eligible for certification in internal medicine, infectious disease, clinical immunology or other related area preferred.
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 Click “Advanced Search” and enter job number 207891 in the Job Opening ID box. OR fax your resume to 240-694-3151. Please specify title and job number on fax.
HJF is a nonprofit medical research organization that provides support services to the military medical community and offers a competitive salary and generous benefits package.
HJF administers innovative medical research, supports education and training, and facilitates collaborations between the military and private medical communities. We provide comprehensive management and scientific services for more than 1,000 basic, clinical and applied research projects conducted around the globe. We also support continuing medical education programs for more than 160 military medical research and treatment facilities, and military medical organizations.