Senior Medical Officer- Clinical Oversight & Pediatric Research

Job Family:

Clinical Trial Operations

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:

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.

What We Offer:

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.

Benefits include:

• 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

About Guidehouse

Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.