Scientific Project Manager

Axle • Rockville, MD

1d • $150,000 - $165,000 • Onsite

About The Position

Axle is seeking a Scientific Project Manager to support the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) in Bethesda, Maryland. The role serves as Team Lead of the Vaccine Research Center (VRC) Clinical Trials Program Data Analysis and Scientific Writing (DASW) team, providing senior scientific and technical leadership for team activities and deliverables. The position coordinates and prioritizes work in alignment with clinical research priorities, study timelines, reporting requirements, and available resources; monitors milestones, dependencies, risks, and constraints; and communicates progress and operational needs to program leadership.

The Scientific Project Manager reviews clinical trial analyses and scientific communications for scientific rigor, accuracy, completeness, consistency, and compliance with applicable requirements. The role provides expertise in immunology, vaccinology, translational research, and clinical evaluation of vaccines and monoclonal antibodies; contributes scientific and analytical input to clinical research planning, protocols, analysis plans, and data management plans; and coordinates scientific review of clinical trial protocols. The position also supports assay readiness, interpretation and integration of clinical and laboratory data, clinical data and sample sharing, and dissemination of research findings through publications and presentations.

The role promotes quality improvement and consistent practices across DASW and Sample Management activities. Responsibilities include coordinating procedural reviews and revisions, participating in quality audits, tracking implementation of improvements, mentoring and training staff, facilitating communication among multidisciplinary teams, and preparing project documentation and status updates. Deliverables include monthly status reports, progress assessments as requested by the Task Leader, ad hoc meetings with laboratory members to present updates, and monthly statements of work.

Requirements

• Ph.D.
• Field of study: Biology, multidisciplinary or general science.
• Experience or capability in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing, applying current scientific and industry best practices.
• Scientific expertise in immunology, vaccinology, translational research, and clinical evaluation of novel vaccines and monoclonal antibodies.
• Skills in medical or scientific computer databases used to search for and collect information.
• Skills in data analysis and graphing.
• Scientific writing and communication skills.
• Project management and website content management skills.
• Ability to use graphing and reference/bibliographic software, MS Office, and SharePoint.

Responsibilities

• Serve as Team Lead of the VRC Clinical Trials Program Data Analysis and Scientific Writing (DASW) team and provide senior scientific and technical leadership.
• Coordinate and prioritize DASW activities and assignments according to clinical research priorities, study timelines, reporting requirements, and available resources.
• Maintain an integrated view of projects and deliverables, including milestones, dependencies, timelines, emerging issues, and resource or schedule constraints.
• Track team activities and deliverables, identify risks or delays, and recommend resolution or escalation to program leadership.
• Serve as a primary DASW point of contact for program leadership and functional teams, participate in Team Leads meetings, and communicate priorities, accomplishments, risks, timelines, and resource needs.
• 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 in analyses and scientific writing through standardized approaches, collaborative review, best practices, and continuous 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 addressed appropriately in analyses and reports, and that conclusions are supported by available data.
• Verify applicable clinical trial results are prepared and reported according to public reporting requirements, established processes, and timelines.
• Support the management and documentation of clinical trial analytical data and verify 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, including documentation and resolution of comments.
• Provide subject-matter expertise and scientific consultation in immunology, vaccinology, translational research, and clinical evaluation of vaccines and monoclonal antibodies.
• Provide input on study objectives, endpoints, sampling strategies, analysis approaches, 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 to monitor assay development, qualification, and readiness; track timelines and communicate dependencies or schedule issues.
• Participate in the Sample Management team and coordinate clinical data and biological sample sharing with approved research collaborators in accordance with applicable requirements.
• Lead or contribute to manuscripts, abstracts, presentations, posters, clinical trial result summaries, and other scientific communications; present findings at approved scientific meetings.
• Support publication planning and tracking to facilitate timely dissemination of research findings.
• Facilitate biannual reviews of DASW work instructions and procedures and recommend revisions to improve quality, consistency, efficiency, and coordination.
• Participate in biannual quality audits of the DASW and Sample Management teams and evaluate relevant findings.
• Draft or coordinate procedural revisions and corrective or improvement measures, monitor implementation, and assess their effectiveness.
• Identify recurring challenges and opportunities to standardize or improve clinical trial analysis, data management, scientific review, and scientific writing processes.
• Facilitate sharing of best practices, lessons learned, and scientific or procedural updates across the team and collaborating program groups.
• Prepare monthly status reports covering current and completed activities, problems, corrective actions, and recommendations for the next reporting period; provide progress reports as requested by the Task Leader.
• Attend ad hoc meetings with laboratory members to present updates and prepare monthly statements of work.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree