Senior Medical Officer-Infectious Diseases & Pharmacovigilance

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

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 [email protected]. 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 [email protected].  Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.  Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact [email protected]. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.