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 the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), by providing clinical safety oversight, medical review, and clinical trial support services. This is a full-time position located in Rockville, MD. Assess serious adverse events (SAEs) from clinical trials. Assess SUSAR notifications from external organizations and evaluate potential impacts on active DMID studies. Perform periodic medical data reviews, including laboratory values, adverse events, coding documentation, tables, listings, and figures. Provide clinical safety oversight and review of DMID-sponsored clinical trial protocols. Review clinical trial protocols and provide recommendations related to safety and operational considerations. Review and provide recommendations regarding the design and safety of clinical trials. Represent DMID in communications with regulatory agencies, sponsors, and academic partners during clinical trial development and implementation. Serve as a medical and scientific subject matter expert for project teams. Collaborate with internal and external stakeholders to support program objectives. Review safety reports and serve as a DMID representative on safety committees. Participate in department meetings, training activities, and safety-related educational programs. Draft policies and guidelines related to clinical safety and study oversight. Provide advice and recommendations regarding clinical trial management. Identify process gaps and implementation challenges and participate in remediation efforts.

What You Will Need:

Medical degree from an accredited university. Minimum of SIX (6) years of medical, clinical research, pharmacovigilance, or clinical trial experience. Experience reviewing clinical trial protocols and safety documentation. Knowledge of adverse event and serious adverse event reporting requirements. Experience supporting clinical trial safety monitoring activities. Proficiency with Microsoft Office applications. 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 infectious disease clinical trials. Prior experience interacting with FDA or other regulatory agencies. Previous service on clinical safety review boards or safety monitoring committees. Strong ability to communicate effectively and work collaboratively in a team environment. Experience developing clinical safety policies and guidance documents. Knowledge of Good Clinical Practice (GCP) and clinical research regulations. 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. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. 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Senior Medical Officer