Position Title: Senior Medical Officer, Full-Time
Contract Duration: 12-month base period with renewable option periods
Location: Rockville, Maryland
Department: Veritas Management Group/NIH SOAR
Summary
Veritas Management Group (VMG) is a leading management consulting firm offering solutions to complex challenges involving public health, technology, and military domains. We serve government and commercial sector organizations, academic institutions, and non-profit organizations, domestically and globally. We are committed to transforming public health through equitable, data-driven solutions.
VMG is seeking an experienced Senior Medical Officer to support the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID). This position provides senior medical leadership and scientific oversight for DMID-sponsored clinical research programs by advising on Institutional Review Board (IRB) processes, pediatric clinical care, hospital pharmacy practices, clinical trial oversight, protocol review, and participant safety. The Senior Medical Officer will collaborate with federal staff, investigators, regulatory agencies, sponsors, and academic partners to support the safe and effective execution of infectious disease clinical trials.
Key Responsibilities
- Provide medical expertise and recommendations regarding Institutional Review Board (IRB) processes and clinical research oversight.
- Advise DMID staff on pediatric clinical care and hospital pharmacy practices related to clinical research.
- Provide guidance on the oversight and administration of clinical trials.
- Review clinical trial protocols and provide recommendations to improve study quality, participant safety, and operational effectiveness.
- Evaluate safety and operational issues associated with DMID-sponsored clinical research protocols.
- Assess Serious Adverse Events (SAEs) reported during clinical trials and provide medical recommendations.
- Review and provide recommendations regarding the design and safety of clinical trials.
- Represent DMID in communications with the U.S. Food and Drug Administration (FDA), study sponsors, and academic partners regarding clinical trial design and safety.
- Review safety reports and serve as a medical safety expert on safety committees.
- Participate in Office of Clinical Research Affairs (OCRA) meetings, training sessions, and safety-related educational programs.
- Develop policies and guidelines that support the care and protection of patients enrolled in DMID-sponsored clinical studies.
- Prepare written reports, medical reviews, recommendations, and other technical documents supporting clinical research activities.
- Collaborate with multidisciplinary research teams to ensure compliance with NIH policies, federal regulations, and Good Clinical Practice (GCP) standards.
- Provide expert medical consultation to investigators, federal leadership, and research partners on complex clinical and regulatory issues.
Required Qualifications
- Medical Degree (M.D. or D.O.) from an accredited medical school.
- Minimum of ten (10) years of professional medical experience in clinical medicine, clinical research, or a related healthcare field.
- Experience supporting clinical trial oversight and protocol review.
- Experience assessing clinical safety issues and Serious Adverse Events (SAEs).
- Knowledge of Institutional Review Board (IRB) processes, FDA regulations, and Good Clinical Practice (GCP).
- Experience providing medical consultation for multidisciplinary clinical research programs.
- Superior medical writing skills.
- Excellent oral and written communication skills.
- Proficiency with Microsoft Office Suite.
Preferred Qualifications
- Board certification in a relevant medical specialty.
- Experience supporting NIH, NIAID, or other federally funded clinical research programs.
- Experience in pediatric clinical care or pediatric clinical research.
- Experience supporting infectious disease clinical trials.
- Experience serving on clinical safety committees or similar oversight groups.
- Experience developing clinical policies, practice guidelines, and research procedures.
- Experience working with FDA-regulated clinical research and sponsor communications.
Work Environment
- Full-time position (40 hours per week).
- Monday through Friday schedule.
- Position is located at the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) in Rockville, Maryland.
- Telework is not available.
- Professional office environment supporting clinical research oversight and medical program administration.
- Position requires close collaboration with physicians, investigators, federal program officials, regulatory agencies, sponsors, academic partners, and multidisciplinary scientific teams.
- No direct patient care responsibilities.
- No security clearance required.
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