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 infectious disease expertise, protocol development support, pharmacovigilance review, and clinical safety consultation. This is a full-time position located in Rockville, MD.
- Review pharmacovigilance reporting strategies, including safety monitoring plans and related safety documentation.
- Support protocol development activities by providing input on study objectives, subject safety, and safety reporting requirements.
- Provide clinical expertise regarding infectious diseases and make recommendations on key clinical issues.
- Serve as a clinical advisor to DMID staff and external stakeholders on study design and safety matters.
- Review incoming safety data, including adverse event reports, safety committee reports, clinical study reports, investigator brochures, package inserts, and scientific literature.
- Conduct comprehensive reviews of clinical protocols and supporting documentation.
- Provide recommendations to clinical investigators and program staff regarding protocol safety and implementation.
- Participate in discussions and presentations involving industry representatives, contractors, grantees, safety monitoring committees, and other stakeholders.
- Maintain proficiency in reviewing and accessing clinical study information from DMID-supported databases.
What You Will Need:- Medical degree from an accredited university.
- Minimum of SIX (6) years of medical, infectious disease, clinical research, or pharmacovigilance experience.
- Experience evaluating safety monitoring plans and adverse event reporting.
- Experience reviewing clinical research protocols and associated study documentation.
- Demonstrated knowledge of infectious disease clinical research.
- 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:- Board certification in an infectious disease-related specialty.
- Experience supporting NIH-sponsored clinical trials.
- Experience presenting to regulatory, scientific, or executive audiences.
- Familiarity with safety monitoring committees and pharmacovigilance programs.
- Strong oral and written communication skills.
- Experience working with clinical research databases and electronic safety systems.
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
