Scientific Project Manager

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. Axle is seeking a Scientific Project Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Bethesda, MD.

Responsibilities

Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing; Monitor the work of the data analysis and scientific writing team members and provide senior scientific and technical leadership for team activities and deliverables; Promote quality and consistency across data analysis and scientific writing team activities and deliverables; Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints; Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in clinical research; Serve as Team Lead of the VRC CTP Data Analysis and Scientific Writing (DASW) team; Coordinate and prioritize DASW activities and assignments in alignment with CTP clinical research priorities; Track team activities and deliverables and identify potential risks, delays, and competing priorities; Serve as a primary DASW point of contact for CTP leadership and other CTP functional teams; Provide technical guidance, mentorship, and training to DASW Scientific Advisors and other team members; Review scientific and analytical deliverables prepared by PhD-level DASW Scientific Advisors; Verify that clinical trial objectives and endpoints related to immunogenicity, pharmacokinetics (PK), and other assigned scientific analyses are appropriately addressed; Review clinical trial analyses and results to assess whether conclusions are scientifically supported; Serve as Chair of the VRC Scientific Review Committee and coordinate the scientific review of VRC clinical trial protocols; Provide subject-matter expertise in immunology, vaccinology, translational research, and the clinical evaluation of novel vaccines and monoclonal antibodies; Provide scientific and analytical consultation during clinical research planning and protocol development; Track assay-development activities and timelines; Participate as a member of the Sample Management team; Lead or contribute to the development and review of manuscripts, abstracts, scientific presentations, posters, and other scientific communications; Present clinical trial findings at approved internal and external scientific meetings and conferences; Support publication planning and tracking of scientific deliverables; Facilitate biannual reviews of DASW work instructions and related procedures; Participate in biannual quality audits of the DASW and Sample Management teams; Draft or coordinate procedural revisions in response to audit findings; Develops project management documentation; Develops and tracks project budgets; Monthly status reports on current and completed activities, problems encountered, corrective actions, and recommendations; Status reports to assess progress, as requested by the Task Leader; Meet with lab members to present updates

Requirements

Ph.D.; Miscellaneous Biology; Multi-Disciplinary or General Science; Graphing and reference and bibliographic software; MS Office; SharePoint; Medical/scientific computer databases to search and collect information; Designing and creating documents, using desktop publishing software and office tools; Data analysis and graphing; Scientific Writing and Communication; Project management, website content management

Benefits

100% Medical, Dental & Vision Coverage for Employees; Paid Time Off and Paid Holidays; 401K match up to 5%; Educational Benefits for Career Growth; Employee Referral Bonus; Flexible Spending Accounts (Healthcare FSA, Parking Reimbursement Account, Dependent Care Assistance Program, Transportation Reimbursement Account)