Senior Medical Officer

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 infectious disease clinical research by supporting protocol development, evaluating clinical safety strategies, reviewing pharmacovigilance data, and providing expert medical guidance throughout the clinical trial lifecycle. The Senior Medical Officer will work closely with federal staff, investigators, industry partners, and regulatory stakeholders to ensure participant safety, regulatory compliance, and the successful execution of DMID-sponsored clinical research programs.

Key Responsibilities

• Provide senior medical and scientific leadership for DMID-sponsored infectious disease clinical research programs.
• Review pharmacovigilance reporting strategies, including safety monitoring plans and clinical safety oversight procedures.
• Evaluate incoming safety data, including adverse event reports, safety committee reports, clinical study reports, investigator brochures, package inserts, and relevant scientific literature.
• Support protocol development by providing expert recommendations regarding study objectives, participant safety, clinical trial design, and safety reporting requirements.
• Conduct comprehensive reviews of clinical protocols and supporting study documentation.
• Provide detailed feedback and recommendations to DMID staff and clinical investigators regarding protocol design and implementation.
• Serve as a clinical subject matter expert in infectious diseases by providing medical consultation and recommendations on complex clinical issues.
• Advise DMID leadership and scientific staff regarding clinical development strategies, participant safety, and protocol implementation.
• Participate in discussions regarding clinical trial design and safety with DMID leadership, industry representatives, contractors, grantees, and Safety Monitoring Committee members.
• Prepare written reports, presentations, and formal recommendations related to clinical trial design, participant safety, and medical oversight.
• Develop and maintain proficiency in accessing, reviewing, and interpreting clinical study information maintained within DMID databases.
• Collaborate with multidisciplinary teams to ensure clinical research activities comply with NIH policies, federal regulations, and Good Clinical Practice (GCP) standards.
• Support continuous improvement initiatives by identifying clinical, operational, and regulatory issues and recommending solutions that enhance research quality and participant safety.
• Prepare technical reports, scientific summaries, medical reviews, and other documentation supporting DMID-sponsored research activities.

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, infectious diseases, or a related field.
• Experience supporting clinical trial protocol development and clinical safety oversight.
• Experience reviewing pharmacovigilance data, adverse event reports, and clinical safety documentation.
• Knowledge of FDA regulations, Good Clinical Practice (GCP), and federal clinical research requirements.
• Experience providing medical consultation and scientific leadership for multidisciplinary clinical research programs.
• Strong analytical, clinical decision-making, and problem-solving skills.
• Excellent oral and written communication skills.
• Ability to collaborate effectively with multidisciplinary teams and external research partners.
• Proficiency with Microsoft Office Suite.

Preferred Qualifications

• Board certification in Infectious Diseases or another relevant medical specialty.
• Experience supporting NIH, NIAID, or other federally funded clinical research programs.
• Experience in pharmacovigilance, medical monitoring, or clinical safety management.
• Experience interacting with the U.S. Food and Drug Administration (FDA), pharmaceutical sponsors, and academic research organizations.
• Experience serving on Data and Safety Monitoring Boards (DSMBs), Safety Monitoring Committees, or similar clinical oversight groups.
• Experience developing clinical safety policies, guidance documents, and standard operating procedures.
• Knowledge of infectious disease clinical trial design and regulatory requirements.

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 infectious disease clinical research and medical oversight.
• Position requires frequent collaboration with physicians, investigators, federal program officials, industry partners, regulatory agencies, contractors, and multidisciplinary scientific teams.
• No direct patient care responsibilities.
• No security clearance required.