Reports to: Senior Vice President, Research & Development
Location: Washington, DC
The Sabin Vaccine Institute (Sabin) is seeking a vice president of non-clinical development to join its Vaccine Research & Development (R&D) Team. The VP will plan and implement all aspects of Sabin’s pre-clinical/non-clinical development activities and plays a key role in applied research, pharmacology (PK/PD), toxicology, manufacturing and regulatory. The VP will work closely with other internal functional leads as well as external subcontractors and consultants. The VP will leverage his/her expertise in the areas of strategic planning, vaccine development and non-clinical development, including in-vitro assays and animal models for evaluations of vaccine safety and effectiveness. The VP will have a proven track record with investigational new drug (IND) submissions and managing a product from late-stage discovery to the clinic. Drug registration (BLA/NDA) filing experience is preferred. Sabin aims to drive vaccine candidates through FDA licensure; the VP will leverage their robust set of experiences and qualifications to achieve this objective.
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 VP will be an important part of developing a long-term pipeline strategy, developing new project opportunities and project execution.
- 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
- Devise, maintain and guide the implementation of best practices for Sabin’s non-clinical team
- Direct all product specific assays such as PK and ADA bioanalytical methods and IVDs as well as the PK/PD data analysis and reports
- Lead non-clinical POC directly with funding agencies/funders
- Contribute to reporting deliverables to funding agencies/funders
- Provide expertise and scientific direction from non-clinical 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
- Advise and support all cross-functional needs (Regulatory, Quality, CMC, Project Management, Finance, etc.)
- Responsible and accountable for generating, managing and executing 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
- Ensure compliance with internal and external policies and regulations, as applicable
- Pipeline strategy development and external relationship development
- 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
- Advanced degree in a related field, PhD preferred
- 20+ years relevant experience, preferably with vaccine development and in the pharmaceutical or biotech industry
- 15+ years of U.S. Government funded vaccine R&D experience
- Proven expertise in pre-clinical development areas of toxicology, pharmacology, etc. and expert understanding of the interconnections between all other cross-functional areas
- Expertise in running GLP and non-GLP studies in support of the regulatory pathway
- Expertise in designing non-clinical studies requiring biological safety levels up to and including BSL4
- 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 people, 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, 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, Non-Clinical 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 to 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.