Reports to: Senior Vice President, Research & Development
Location: Offices 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. Sabin staff, management and Board of Trustees are committed to developing a diverse, equitable and inclusive team.

Position Summary:

The Vice President (VP), Research & Development (R&D) plans and implements all aspects of Sabin’s pre-clinical/non-clinical development activities and plays a key role in applied research, assay development, pharmacology (PK/PD), toxicology, manufacturing, process, analytics and regulatory. The VP works closely with other internal functional leads as well as external subcontractors and consultants. The VP leverages their expertise in the areas of:

  • Non-clinical development in support of licensure pathways under FDA’s Animal Rule, specifically the regulations that set forth the pathway for approval of these products under 21 CFR 314.600 through 314.650 (drugs) or 21 CFR 601.90 through 601.95 (biological products);
  • Animal models and regulatory compliance for evaluations of vaccine safety and effectiveness;
  • Transitional immunology and immunobridging under Animal Rule; and,
  • Assay development.

The VP has a proven track record with investigational new drug (IND) submissions and managing a product from late-stage discovery to the clinic. Sabin aims to drive vaccine candidates through FDA licensure; the VP will leverage their robust set of experiences and qualifications to achieve this objective.

Responsibilities:

Non-Clinical/Pre-Clinical Product Development

  • Lead all aspects of Sabin’s non-clinical vaccine R&D projects, including animal model and assay development
  • Devise non-clinical development plans in support of the overall product development strategy and regulatory pathway
  • Lead immunobridging/translational immunology
  • Devise, maintain and guide the implementation of best practices and regulatory compliance for Sabin’s non-clinical team
  • Direct all product specific assays such as immunogenicity, PK and ADA bioanalytical methods and IVDs as well as the immunogenicity, PK/PD data analysis and reports
  • Lead non-clinical POC discussions directly with regulators and funding agencies/ organizations
  • Contribute to reporting deliverables to Sabin’s R&D Committee, regulators and funding agencies/organizations

CMC Management

  • Manage outside consultant who is responsible for Sabin’s R&D vaccine manufacture projects, including process development, non-GMP and GMP manufacturing and campaigns, and process and analytical development of vaccine candidates
  • Provide technical vaccine manufacturing and chemistry leadership
  • Interpret, summarize and present R&D results at internal and external scientific meetings

Business Development

  • Work in collaboration with Sabin executive and senior leadership to support growth of product pipeline; strategy development and external relationship development
  • Participate in due diligence activities and lead non-clinical assessment of vaccine candidates
  • Use business network to identify possible vaccine candidates for further development by Sabin
  • Participate in funding applications; lead all non-clinical portions of applications

Collaboration/Partner Management

  • Provide leadership, expertise and scientific direction from non-clinical and CMC perspective in association with cross-functional teams
  • Identify and manage outside subcontractors and consultants, as appropriate
  • Perform data analysis and prepare or review final reports for studies conducted by third parties
  • Generate, manage and execute program deliverables on time and in budget
  • Exercise cost-effective quality and regulatory compliant methods in selecting program partnerships and involve all stakeholders in driving decisions
  • Support budget development and staffing projections

Program Management

  • Ensure compliance with internal and external policies and regulations, as applicable
  • Advise and support all cross-functional needs (Regulatory, Quality, Clinical Project Management, Finance, etc.)
  • Recruit qualified talent, supervise, mentor, coach and train team members, as assigned
  • Represent Sabin and promote its mission at events and meetings
  • Other related duties, as assigned

Requirements:

  • Advanced degree in a related field, PhD preferred
  • 16+ years relevant experience, preferably with vaccine development and in the pharmaceutical or biotech industry
  • Experience in U.S. Government funded vaccine R&D settings preferred
  • Proven expertise in pre-clinical development, translational immunology and immunobridging between clinical and non-clinical development
  • Expertise in running FDA compliant GLP and non-GLP studies
  • Expertise in designing non-clinical studies requiring biological safety levels up to and including BSL3, BSL4 preferred
  • Experience in utilizing the Animal Rule and Accelerated Approval regulatory pathways
  • Well-versed in creating and managing timelines and budgets, identifying risks and contingency planning
  • Proven ability to manage cross-functional teams, build relationships and understand what motivates others
  • Excellent verbal and written communicator with ability to tailor approach toward the perspective of others
  • Demonstrated ability to interact effectively with individuals at all levels, including Boards of Trustees, coalition partners, staff and organizational contacts; excellent at working closely with others over geographical distance
  • Strong attention to detail and scientific writing skills, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands in order 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

How to Apply:

To be considered, please submit your cover letter and resume via e-mail to [email protected] Please be sure to reference “Vice President, Research & Development” in the subject line. Applications without a cover letter will not be considered. 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 (see https://www.sabin.org/careers/employee-benefits).

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.