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    Medical Officer - Bethesda, United States - Nextonic Solutions LLC

    Nextonic Solutions LLC
    Nextonic Solutions LLC Bethesda, United States

    3 weeks ago

    Default job background
    Description
    Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Medical Officer to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), TB Clinical Research Branch (TCRB), Therapeutics Research Program (TRP), Division of AIDS (DAIDS).

    Technical Requirements:
    • Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of 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.
    • Advise program management of merits and deficiencies in proposed clinical studies.
    • 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.
    • Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 15 and 16 of the IND application (FDA Form
    • Evaluate annual IND annual reports for medical safety and report findings to RAB.
    • Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and makes appropriate recommendations to DAIDS' leadership to ensure trials are conducted according to protocol.
    • 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.
    • 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.
    • 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.
    Specific Qualifications:
    • MD degree is required.
    • Minimum of twenty (20) years overall experience in clinical medicine (including at least 3 years in clinical trials research as well as a minimum of 3 years total experience in clinical Tuberculosis care and/or clinical Tuberculosis research).
    Visa Sponsorship:

    No

    Agency / Institute:

    NIH/NIAID
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