Medical Officer - Aids Therapeutics Research Program

Axle 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), Division of AIDS Therapeutics Research Program, HIV Research Branch,.
Responsibilities

• Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, 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 17 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.
   

Experience Required / Requirements

• MD degree from an accredited university.
• Minimum of 20+ years experience in clinical trials research.
• Experience with IND application.

Nice to have:

• AIDS-HIV research experience.

Benefits
​​​​​

• 100% Medical, Dental & Vision premium coverage for Employees.
• Paid Time Off (Including Holidays).
• Employee Referral Bonus.
• 401K Match.
• Tuition reimbursement and professional development opportunities.
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN) 

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