Medical Officer

Axle•Rockville, MD

9h•$185,000 - $195,000

About The Position

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is looking to add a driven, flexible, organized, and meticulous Medical Officer to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Division of AIDS (DAIDS), Vaccine Research Program (VRP), Vaccine Clinical Research Branch (VCRB).

Requirements

M.D. degree required and 20+ years experience in clinical trials research.
The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract.

Responsibilities

Participate in the review, planning and implementation of clinical trials for the prevention and/or treatment of HIV, its 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 1571).
Evaluate annual IND 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.