Position Objective: Provide services as a Scientific Program Manager (T-Cell) in support of the overall functions of the Vaccine Research Center (VRC), Translational Science Team (TST) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• Provide subject-matter scientific expertise to the Clinical Trials Program leadership in immunology and clinical evaluation of novel vaccines and monoclonal antibodies.
• Provide training to trainees, coordinate and distribute workflow and tasks for trainees.
• Review and provide feedback, to include:
  • Analysis and interpretation of clinical trial immunogenicity data (T-cell response, humoral immunity, innate immunity).
  • Preparation of manuscripts for publication with clinical trial results.
  • Preparation of documents and presentations for internal and external communication of clinical trial results.
• Act as Scientific Review Chair on developing protocols for VRC Clinical Trial Protocols.
• Coordinate with VRC leadership and Clinical Trials Program (CTP) to strategize overarching goals of ongoing trials.
• Optimize team processes and work instructions and improve communication with other VRC groups to streamline workflow and transfer of information.
• Monitor/regulate online secure data storage for clinical trial immunological results.
• Track project progression throughout the trial, from protocol development until final presentation or manuscript acceptance, to ensure timelines are met.
• Act as corresponding author for journals on clinical trial manuscripts
• Review and approve trial Analytical Plans outlining all immunological laboratory analysis to be performed by the VRC Vaccine Immunology Program (or other testing laboratory).
• Prepare required scientific or technical documents including Analytical Plan, Work Instructions, publications and protocols.
• Understand clinical and immune assessment assays to educate program leadership, clinical trial principal investigators (PIs), the scientific community, peers and lay persons.
• Summarize results of T-cell, humoral immunity and innate immune response data.
• Author descriptions of data for publications and reports.
• Graph and format previously analyzed data for presentation.
• Prepare manuscripts for publication in scientific journals, technical reports, and presentations for meetings and lectures.
• Edit and revise original manuscripts for submission to leading scientific journals.
• Maintain scientific journal reference manager programs; coordinate a variety of reports related to scientific journal requests.
• Record raw data according to good practice; file data accessibly; maintain accessible notebooks.
• Provide raw data to collaborators and internal clinical online repository upon approved request.
• Contribute laboratory findings to research publications.
• Provide guidance related to clinical trials to laboratory staff.
• Participate in planning of new projects; provide expert advice and consultation on analysis techniques and novel assays.
• Write and review technical protocols and reports documenting analytical development studies pertaining to his/her work.

Basic Qualifications:

• Ph.D. in Biomedical Science, Biology or a related discipline.
• Minimum of five (5) years of related experience; demonstrates knowledge of a broad range of scientific and technical areas.
• Experience in understanding and analyzing complex biomedical information and research findings.
• Skilled in designing and creating documents, using desktop publishing software and office tools.
• Skilled in using medical/scientific computer databases to search and collect information.
• Knowledge of graphing and reference and bibliographic software.

Minimum Qualifications:

• Ability to maintain and develop sources of information to gather data and transmit findings in areas of biomedical science.
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• 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.

This position is contingent upon contract award.