Senior Medical Officer- Clinical Oversight & Pediatric Research

Senior Medical Officer

We are looking for a Senior Medical Officer to support NIAID/DMID by providing expert guidance on clinical trial oversight, Institutional Review Board (IRB) processes, pediatric clinical care considerations, and clinical safety management. This is a full-time position located in Rockville, MD.

• Provide advice and recommendations regarding Institutional Review Board (IRB) processes, pediatric clinical care, hospital pharmacy operations, and related healthcare communities.
• Provide expert guidance on the oversight of clinical trials.
• Review clinical trial protocols.
• Review and comment on safety and operational issues associated with DMID-sponsored protocols.
• Assess serious adverse events arising from clinical trials.
• Review and provide recommendations regarding the design and safety of clinical trials.
• Represent DMID in communications with FDA representatives, sponsors, and academic collaborators regarding clinical trial design and implementation.
• Review safety reports and serve as a safety expert on committees.
• Participate in standing department meetings, training, and educational activities.
• Draft policies and guidelines affecting participants enrolled in DMID-sponsored studies.

What You Will Need:

• Medical degree from an accredited university.
• Minimum of SIX (6) years of medical, pediatric, clinical research, or clinical trial oversight experience.
• Experience supporting IRB review processes and clinical study oversight.
• Experience reviewing clinical trial protocols and safety reports.
• Knowledge of clinical trial safety monitoring and regulatory compliance.
• Proficiency with Microsoft Office applications.
• Superior medical writing skills.
• Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.

What Would Be Nice To Have:

• Experience supporting pediatric clinical research programs.
• Familiarity with hospital pharmacy operations and medication safety programs.
• Experience drafting medical policies, procedures, and regulatory guidance.
• Experience participating on safety review committees.
• Knowledge of FDA regulations and Good Clinical Practice (GCP).

The annual salary range for this position is $85,000.00-$141,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus