Scientific Program Manager

at  Axle

(ID: 2024-5088)
Axle Informatics 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 around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

OVERVIEW

Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR) / Laboratory of Immune System Biology (LISB).

TECHNICAL REQUIREMENTS:

• Provide accountability for the scientific deliverables and contributions of the Vaccine Research Center’s (VRC) Translational Science Team.
• Oversee essential team functions, ensuring that: All scientific objectives of VRC clinical trials are met; Clinical trial data is accurately analyzed and project timelines established by VRC leadership are met.
• VRC clinical trial data is managed according to best practices and securely archived in digital data management platforms.
• Clinical trial data is accurately communicated in a timely fashion to the public, VRC leadership and internal teams, and external stakeholders including academia, government and industry partners.
• Serve as the Scientific Review Chair in the development of VRC clinical trial protocols to provide subject matter expertise and scientific oversight.
• Perform complex data analysis on first in-human clinical trial data, involving multiple procedures and a variety of technical approaches, including statistical and multivariant modeling.
• Process, analyze and interpret large, complex primary clinical trial datasets.
• Develop novel methodologies for analyzing immunological and pharmacokinetic data from both vaccine and monoclonal antibody clinical trials.
• Develop protocol scientific objectives and analytical laboratory testing plans for first-in-human clinical trials testing vaccines and therapeutics for infectious diseases.
• Prepare high level executive summaries of data for senior leadership to use in key decision Making.
• Prepare complex scientific reports for publication in top-tier peer reviewed scientific journals.
• Provide expert advice and consultation related to clinical trials to laboratory and research staff.
• Provide insight to VRC Primary Investigators, scientists, and research staff on clinical and immune assessments assays.
• Author descriptions of complex immune response data and clinical trial results for regulatory reports, product licensees and internal and external stakeholders. • Provide peer review as a scientific expert for original scientific manuscripts.
• Effectively collect, organize, store, protect, and process data; ensure useability of datasets.
• Lead and manage secure storage of clinical data on digital data management platforms according to industry standards and best practices.
• Provide raw data to collaborators and post to online repositories upon approved requests/as required by NIH data sharing standards.
• Assist FTL with integration of new team members by training junior team members to follow internal work instructions and standard operating procedures (SOPs) pertaining to data analysis and data management.
• Provide guidance related to clinical trials to laboratory staff.
• Participate in planning of new projects; provide expert advice and consultation on development of clinical trial protocols, analytical laboratory testing plans, and statistical analysis plans.
• Write and review technical protocols, work instructions, and reports documenting analytical development studies.

SPECIFIC QUALIFICATIONS:

• Ph.D. in Biomedical Science, Biology or a related discipline.
• Minimum of two (2) 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.
• Ability to maintain and develop sources of information to gather data and transmit findings in areas of biomedical science.
• Skill in designing and creating documents, using desktop publishing software and office tools.
• Skill in using medical/scientific computer databases to search and collect information.
• Knowledge of graphing and reference and bibliographic software.
  The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
  Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
  Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed

Please refer the Job description for details