Medical Officer

3 weeks ago

Rockville, United States Axle Full time
Job DescriptionJob Description

(ID: 2024-5211)

Axle Informatics 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).

Benefits:

  • 100% Medical, Dental & Vision 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)
Overview:Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Therapeutics Research Program (TRP), TB Clinical Research Branch (TCRB).
Technical Requirements:
  • Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, 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.
Specific Qualifications:
  • MD degree in a related field.
  • 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).

The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com

Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individual's assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

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