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
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 clinical safety oversight for DMID-sponsored clinical trials by reviewing study protocols, evaluating safety data, providing medical and scientific expertise, and supporting the development and implementation of clinical research programs. The Senior Medical Officer will collaborate with federal staff, investigators, regulatory agencies, sponsors, and academic partners to ensure participant safety, regulatory compliance, and the successful execution of infectious disease clinical research.
- Provide medical oversight and clinical safety expertise for DMID-sponsored clinical trials and research programs.
- Review clinical trial protocols and provide recommendations regarding study design, participant safety, and operational feasibility.
- Evaluate Serious Adverse Events (SAEs) reported during clinical trials and provide medical assessments and recommendations.
- Review Suspected Unexpected Serious Adverse Reaction (SUSAR) notifications received from external sponsors and assess their impact on active DMID clinical studies.
- Conduct periodic medical data reviews, including evaluation of laboratory values, adverse events, clinical coding documentation, data listings, tables, and figures.
- Review and provide recommendations regarding the design, implementation, and safety monitoring of clinical trials.
- Represent DMID in scientific and regulatory communications with the U.S. Food and Drug Administration (FDA), study sponsors, investigators, and academic collaborators.
- Serve as the medical and scientific subject matter expert on multidisciplinary clinical research project teams.
- Participate in internal project meetings and collaborate with federal staff and external research partners to advance clinical research objectives.
- Review safety reports and serve as the DMID representative on clinical safety committees and safety review boards.
- Participate in Office of Clinical Research Affairs (OCRA) meetings, training sessions, and safety-related educational programs.
- Develop and update clinical safety policies, procedures, and guidance documents supporting DMID-sponsored clinical trials.
- Provide medical consultation and strategic guidance regarding the management of clinical trials.
- Identify operational and clinical process gaps, recommend corrective actions, and assist with implementation of process improvements.
- Prepare scientific reports, safety summaries, regulatory documentation, and technical recommendations for leadership and stakeholders.
- Medical Degree (M.D. or D.O.) from an accredited medical school.
- Minimum of ten (10) years of professional medical experience supporting clinical research, clinical development, or patient care.
- Experience reviewing clinical trial protocols and evaluating participant safety.
- Experience assessing Serious Adverse Events (SAEs), adverse event reporting, and clinical safety data.
- Knowledge of FDA regulations, Good Clinical Practice (GCP), and clinical trial safety requirements.
- Experience providing medical leadership for multidisciplinary clinical research programs.
- Strong analytical, clinical decision-making, and problem-solving skills.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to work collaboratively within multidisciplinary scientific and clinical teams.
- Proficiency with Microsoft Office Suite.
- Board certification in a relevant medical specialty.
- Experience supporting NIH, NIAID, or other federally funded clinical research programs.
- Experience supporting infectious disease clinical trials.
- Experience interacting with the U.S. Food and Drug Administration (FDA) and other regulatory agencies.
- Experience serving on Data and Safety Monitoring Boards (DSMBs), Safety Review Committees, or similar oversight committees.
- Experience developing clinical safety policies, standard operating procedures, and regulatory guidance.
- Knowledge of pharmacovigilance, clinical risk management, and medical monitoring principles.
- 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 close collaboration with physicians, investigators, federal program officials, regulatory agencies, sponsors, and multidisciplinary research teams to support the safe conduct of DMID-sponsored clinical trials.
- No direct patient care responsibilities.
- No security clearance required.
