Scientific Project Manager

Axle•Rockville, MD
•$150,000 - $165,000•Onsite

About The Position

Axle is seeking a Scientific Project Manager to join its team at the National Institutes of Health (NIH), supporting the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland. The role serves as Team Lead of the Vaccine Research Center (VRC) Clinical Trials Program (CTP) Data Analysis and Scientific Writing (DASW) team, providing senior scientific and technical leadership across team activities and deliverables. The position coordinates and prioritizes DASW work in alignment with clinical research priorities, study timelines, reporting requirements, and available resources. It maintains an integrated view of projects, milestones, dependencies, risks, and constraints; tracks progress; communicates updates to program leadership; and facilitates coordination among scientific, clinical, laboratory, statistical, data management, regulatory, and operational personnel. The Scientific Project Manager reviews clinical trial analyses, scientific documents, and communications for rigor, accuracy, completeness, consistency, and compliance with applicable requirements. The role provides scientific consultation on study planning, protocols, endpoints, assays, data analysis, and interpretation, with subject-matter expertise in immunology, vaccinology, translational research, and clinical evaluation of vaccines and monoclonal antibodies. It also chairs the VRC Scientific Review Committee, supports scientific review of protocols, and coordinates assay readiness and clinical data and biological sample sharing with approved collaborators. Additional work includes leading or contributing to manuscripts, abstracts, presentations, posters, and trial-result summaries; mentoring and training team members; reviewing and improving work instructions and procedures; participating in quality audits; developing corrective and process-improvement measures; and sharing best practices across teams. The position prepares operational updates and project management documentation and supports dissemination of research findings. The anticipated base compensation range is $150,000–$165,000 USD. Actual salary may vary based on experience, qualifications, skills, and location.

Requirements

  • Ph.D. (listed under certifications and licenses).
  • Field of study in Miscellaneous Biology or Multi-Disciplinary or General Science.
  • Scientific expertise in immunology, vaccinology, translational research, and clinical evaluation of vaccines and monoclonal antibodies.
  • Experience or capability in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing.
  • Ability to review scientific and analytical work for scientific rigor, accuracy, completeness, consistency, and compliance with applicable requirements.
  • Skills in scientific writing and communication, project management, and website content management.
  • Ability to use medical and scientific computer databases to search for and collect information.
  • Ability to design and create documents using desktop publishing software and office tools.
  • Skills in data analysis and graphing.
  • Knowledge of graphing, reference, and bibliographic software; MS Office; and SharePoint.

Responsibilities

  • Serve as Team Lead of the VRC CTP Data Analysis and Scientific Writing team, providing senior scientific and technical leadership.
  • Coordinate and prioritize team activities and assignments according to clinical research priorities, timelines, reporting requirements, and resources.
  • Maintain an integrated view of projects, milestones, dependencies, timelines, issues, and resource or schedule constraints.
  • Track deliverables and risks, identify delays or competing priorities, and recommend resolution or escalation to program leadership.
  • Serve as a primary point of contact for program leadership and functional teams, participate in Team Leads meetings, and provide operational updates.
  • Facilitate coordination among DASW members and clinical, laboratory, statistical, data management, regulatory, operational, and other research personnel.
  • Provide technical guidance, mentorship, training, onboarding support, and knowledge transfer to team members.
  • Promote quality and consistency through standardized approaches, collaborative review, best practices, and continuous process improvement.
  • Review scientific and analytical deliverables for rigor, accuracy, completeness, consistency, and adherence to requirements.
  • Verify that clinical trial objectives and endpoints, including immunogenicity and pharmacokinetics, are appropriately addressed in analyses and reporting.
  • Assess whether trial conclusions are supported by available data and are presented accurately across reports and scientific communications.
  • Verify preparation and reporting of applicable clinical trial results according to public reporting requirements and established processes and timelines.
  • Support management and documentation of clinical trial analytical data and verify that final data and analyses are maintained or archived in designated systems.
  • Review scientific content for publications, trial result summaries, presentations, posters, and other communications.
  • Chair the VRC Scientific Review Committee and coordinate scientific review of clinical trial protocols.
  • Facilitate timely scientific reviews, document reviews, and resolution of comments supporting protocol development.
  • Provide subject-matter expertise in immunology, vaccinology, translational research, and clinical evaluation of novel vaccines and monoclonal antibodies.
  • Consult on research planning and protocol development, including objectives, endpoints, sampling strategies, and analysis and interpretation approaches.
  • Review and provide scientific input on Data Management and Sharing Plans, Analytical Plans, Statistical Analysis Plans, and related study documents.
  • Collaborate with investigators and multidisciplinary teams to align protocol objectives, laboratory assessments, analytical methods, and planned statistical analyses.
  • Coordinate with laboratory and research scientists on development, qualification, and readiness of assays for clinical trial objectives and endpoints.
  • Track assay-development activities and timelines, identify dependencies or schedule variances, and communicate significant issues and recommendations.
  • Facilitate integration and interpretation of clinical and laboratory data.
  • Participate in the Sample Management team and coordinate clinical data and biological sample sharing with approved collaborators under applicable protocols and agreements.
  • Provide scientific consultation on selecting and using clinical samples and associated data for collaborative translational research.
  • Lead or contribute to manuscripts, abstracts, presentations, posters, clinical trial result summaries, and other scientific communications.
  • Present findings at approved internal and external scientific meetings and conferences.
  • Support publication planning and tracking of scientific deliverables.
  • Facilitate biannual reviews of team work instructions and procedures and recommend revisions.
  • Participate in biannual quality audits of DASW and Sample Management teams and evaluate relevant findings.
  • Draft or coordinate procedural revisions and corrective or improvement measures in response to audit findings, recurring issues, changing requirements, or improvement opportunities.
  • Monitor implementation and effectiveness of approved procedural changes.
  • Identify trends and opportunities to improve clinical trial analysis, data management, scientific review, and scientific writing processes.
  • Prepare educational materials and share best practices, lessons learned, and scientific or procedural updates across teams.
  • Interact with scientists to help address technical hurdles or provide expertise regarding scientific protocol preparation.
  • Develop project management documentation, monitor progress, and report on priorities, accomplishments, timelines, risks, and resource needs.

Benefits

  • 100% medical, dental, and vision coverage for employees.
  • Paid time off and paid holidays.
  • 401(k) match up to 5%.
  • Educational benefits for career growth.
  • Employee referral bonus.
  • Flexible spending accounts, including healthcare FSA, parking reimbursement, dependent care assistance, and transportation reimbursement.
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