Medical Officer (Clinical Trials) (50013)

Position Objective: Provide services as a Medical Officer (Clinical Trials) in support of the overall functions of the Vaccine Clinical Research Branch Vaccine Research Program DAIDS.

Duties and Responsibilities:

• Participate in the review planning and implementation of clinical trials for the prevention and/or treatment of HIV it 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 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• Ability to work independently multitask and pay close attention to detail.
• Strong written oral and visual communication skills.
• Ability and willingness to work on a team excellent customer relations.
• Proficiency with Microsoft Word PowerPoint or other equivalent software suites

*This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required by this position.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Qualified applicants will receive consideration for employment without regard to race color religion sex national origin disability protected veteran status or other characteristics protected by law.