Position Objective: The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) improves national preparedness for chemical, biological, radiological, and nuclear (CBRN) accidents and attacks, pandemic influenza, and emerging infectious diseases by supporting the development and acquisition of medical countermeasures (MCM) against these threats.

The Division of Influenza and Emerging Infectious Diseases (IEID) is currently seeking an Immune Assay Technical Project Manager with strong organizational skills to support the immune assay development and management for COVID-19 vaccines, including for Project NextGen immune assays in support of vaccine clinical operations, which involves remote and decentralized trials. The ideal individual for this role is an effective communicator and an energetic self-starter with strong project management skills who can provide immune assays technical expertise and is comfortable operating in a fast-paced environment. This position is fully remote and requires a candidate to be able to obtain and maintain a Public Trust clearance.

Duties and Responsibilities:

• Manage relationships with internal and external stakeholders and interagency partners; coordinate and integrate to advance program agendas and facilitate implementation.
• Conduct outreach (unscheduled or unprompted) and engage frequently to gather information used to lead strategy and direction of program.
• Apply technical knowledge of immune assays to support clinical studies and clinical operations.
• Coordinate with CROs on shipping, storage, labeling, and other mechanics of sample coordination.
• Provide support for Phase I, IIa, IIb, remote, and D-COHRe trials.
• Develop briefing materials and reports; interpret input from senior leadership and stakeholders and reword in different ways for different audiences.
• Proactively identify needs, risks, and questions and provide potential solutions or prepare responses as appropriate.
• Provide technical expertise to operationalize scientific program strategies and requirements.
• Provide program management and project management support, including tracking contracting issues.
• Schedule, coordinate, and prepare for meetings.

Basic Qualifications:

• PhD in biological sciences, chemistry, pharmaceutical sciences, or related discipline OR equivalent combination of MS or BS degree and significant immune assay experience
• Understanding of vaccinology, including vaccine development, policy, and implementation; understanding of context and what questions to ask
• Demonstrated understanding of health sciences terminology, biology, and laboratory work
• Extensive program and project management experience, including adherence to milestones, cost, budget, and risks
• Ability to obtain and maintain Public Trust Clearance

Minimum Qualifications:

• Priority given to candidates with expertise in immune assays or immunology.
• Prior experience working with government institutions or biopharmaceutical industry experience.
• Excellent written and verbal communication skills including experience with unstructured verbal interactions, briefings, and meeting moderation.
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Ability to work independently and proactively; willingness to roll up their sleeves and get their hands dirty with hard work
• Ability to blend project management and technical skills with minimal supervision.
• Confidence in reaching out to people and soliciting information/updates
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.