Position Level: Senior Manager
Reports to:  Senior Director, Analytical Development & Translational Immunology
Location: Office in Washington, DC; Option to Work Remotely in US Only
 
Why Sabin:
 
Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization.
 
Position Summary: 
 
The Sabin Vaccine Institute (Sabin) is seeking a Research Scientist to join its Vaccine Research & Development (R&D) Team. The incumbent will work with the Senior Director, Analytical Development & Translational Immunology and other R&D colleagues to support aspects of Sabin’s pre-clinical/non-clinical development activities. This is a key technical role in applied research to support immunobridging data.  The successful candidate will support clinical research organizations in assay troubleshooting and sample shipment/testing logistics and to support data analysis for translational immunology application.  Experience working collegially cross-functionally as part of R&D, with guidance from quality assurance, clinical teams, project managers and contracting, is required. The incumbent will support investigational new drug (IND) submissions as Sabin drives vaccine candidates through FDA licensure. 
 
Initially, Sabin’s R&D projects will focus on prophylactic candidate vaccines to protect against Ebola Sudan and Marburg virus funded by the U.S. Government. Sabin is taking proactive action to grow its project pipeline and the incumbent will be an important part of developing a long-term pipeline strategy, developing new project opportunities and project execution.
 
Responsibilities:
 
Research Scientist Functions
  • Support Sabin’s compliance and data reporting objectives across clinical and non-clinical vaccine R&D projects by following up to complete action items, review minutes and/or audits
  • In collaboration with the Senior Director, Analytical Development & Translational Immunology  and R&D team, devise plans in support of the overall product development strategy with a focus on successful immunobridging data 
  • Communicate clearly to a wide range of internal Sabin audiences to develop plans to produce data to support regulatory and funding partner requests 
  • Support data review of product specific assays (ELISA, Ad-neut, PsVNA, stability), bioanalytical (SDS-PAGE, SEC, W. blot) methods and PK/PD data analysis and reports
  • Contribute to deliverables and presentation slides for funding agencies/funders
  • Perform data analysis and prepare or review final reports for studies 
  • Check program deliverable timelines and budget; adjust timelines and/or budget if a delay occurs, updating stakeholders of any downstream impact(s) as needed
  • Exercise cost-effective quality and regulatory compliant methods in driving decisions
 
 
Cross-Functional R&D Management
  • Support assay development or non-clinical data review for regulatory submissions including, but not limited to New INDs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality and reports to partners providing regulatory updates
  • Work with project management team to mitigate/resolve issues and/or deviations from target timelines; provide support as needed
  • Participate in projects as assigned to facilitate best practices 
  • Coordinate the maintenance of work process tools to promote efficiency and productivity (e.g. templates, SOPs, work instructions, checklists, trackers, etc.)
  • Review literature, attend meetings, etc. as needed to stay current 
  • Coordinate across clinical and non-clinical teams to ensure harmonization and knowledge sharing
  • Provide proof reading and editing 
  • Ensure that records are complete, accurate, and current
 
Organizational Management
  • Ensure compliance with internal and external assay testing contracts, as applicable
  • Represent Sabin and promote its mission at scientific events and basic research meetings
  • Other related duties, as assigned
 
Requirements:
 
  • Bachelor’s degree in a related field; advanced degree preferred
  • 9+ years relevant experience, preferably in vaccine development and in the pharmaceutical or biotech industry
  • Proven experience with U.S. Government funded vaccine R&D 
  • Expertise in utilizing the Animal Rule and Accelerated Approval regulatory pathways
  • Expertise in pre-clinical development areas and understanding of the interconnections between all other cross-functional areas
  • Experience with GLP and non-GLP assays and data analysis
  • Experience in designing studies requiring biological safety levels 
  • Ability to identify risks and skilled at contingency planning
  • Proven ability to mentor and coach people; able to build relationships and understand what motivates others
  • Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines
  • Demonstrated ability to operate with purpose, urgency and accuracy in a fast-paced and deadline-driven environment
  • Ability to travel with notice
 
Other:
 
  • Subject to a criminal background investigation
  • Request for three professional references
 
Attributes That Are Important to Sabin:
 
  • Diversity, Equity and Inclusion
  • Problem-Solving and Critical Thinking
  • Decision-Making
  • Communication and Professionalism
  • Initiative and Ownership
  • Productivity and Quality Control
  • Professional Development/Personal Learning
 
How to Apply:
 
To be considered, please submit your cover letter and resume via e-mail to [email protected] Please be sure to reference “Research Scientist, Research & Development” in the subject line. Your cover letter should: (1) address the reasons for your interest in this position; and (2) describe the knowledge, skills and abilities you would bring the Sabin Vaccine Institute. No phone calls, please. Only short-listed candidates will be contacted.
 
Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package.
 
Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.