Medical Officer (TB Clinical Research) - NIH

TASKS

(1) Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of Tuberculosis (TB), HIV/AIDS, co-infections, and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study.

(2) Advise program management of merits and deficiencies in proposed clinical studies.

(3) Provide subject matter expertise during protocol development leading to review at the Division level and ensures that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner.

(4) Provide clinical expertise to assist in developing and reviewing Investigational New Drug (IND) applications particularly the safety of the drug in question

(5) Evaluate annual IND annual reports for medical safety and report findings to Regulatory Affairs Branch (RAB).

(6) Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and makes appropriate recommendations to Division of AIDS (DAIDS) leadership to ensure trials are conducted according to protocol.

(7) Provide clinical and scientific information for preparing NIAID communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies and Data Safety Monitoring Boards.

(8) Conducts site visits, when necessary, to obtain additional data and information for use by federal staff, in the consideration and evaluation of ongoing and future programs.

(9) Preview serious adverse event (SAE) reports, provides expert medical advice for potential impact of SAEs in ongoing research and participates in the preparation of reports submitted to the FDA.

REQUIREMENTS

(1) MD degree in a related field.

(2) Minimum of 20 years of overall experience in clinical medicine, which includes at least 3 years of clinical trials research and a minimum of 3 years of clinical tuberculosis care and/or clinical tuberculosis research