Director, Advancing Rotavirus Vaccine Development (ARVAC) Projects
PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through our work in more than 70 countries, PATH and our partners empower people to achieve their full potential.
PATH’s Vaccine Development Global Program (VAC) is working to accelerate the development of new vaccines targeted against rotavirus, influenza, respiratory syncytial virus (RSV), pneumococcus, ETEC, Shigella, polio and meningococcus. The goal is to develop new safe, effective, affordable vaccines which are appropriate for use in the developing countries that most urgently need them.
VAC is currently working in partnership with various organizations to develop several new rotavirus vaccines; this position would lead two of those development programs (one of which is in late stage clinical development and the other is about to enter clinical development).
The director of the ARVAC projects will be responsible for the scientific direction, management, and implementation of rotavirus vaccine development activities, achieving project milestones, and representing the project to the donors and collaborating partners. Specific responsibilities include:
- Develop and direct the overall strategy as well as scientific and technical implementation of the rotavirus vaccine projects underway with Bharat Biotech, India (ROTAVAC®), and the Wuhan Institute for Biological Products, China (Bovine-Human Reassortant Rotavirus Vaccine [BRV]).
- In collaboration with our partners, manage a portfolio of research, vaccine development, regulatory, and WHO prequalification activities in support of new rotavirus vaccine development.
- Manage all aspects of the project for which PATH is responsible, including: business strategy, fundraising, administrative and financial management, program planning and review, and coordination with partners. Responsibilities include development of new proposal(s) to donor(s) for follow-on funding.
- Initiate and ensure appropriate consultation with vaccine-specific and strategic advisory groups; manage the technical evaluation and programmatic review of projects for the PATH Vaccine Solutions Board of Directors and other advisory boards.
- Manage the ethical clearance and monitoring process to assure that all clinical studies are in compliance with the highest standards of ethical research.
- Interact with national regulatory authorities and the WHO as appropriate.
- Present data at scientific meetings and represent PATH at international, regional, and national meetings; participate in vaccine development conferences and prepare technical reports.
- Collaborate with other vaccine development projects in VAC, especially the other rotavirus vaccine projects, to exchange information, lessons learned, and to maximize utilization of shared resources and foster strategic links.
- Collaborate with PATH’s other vaccine programs, such as with the Malaria Vaccine Initiative and the Vaccine Access and Delivery Global Program, as well as with our Technology Solutions program working on vaccine formulation and delivery devices, as appropriate.
- Other duties as assigned.
- Significant experience with the planning, design, and execution of experimental studies and the interpretation of experimental data.
- Significant experience in new vaccine development (late stage development highly desirable).
- Expert in International Conference on Harmonization Good Clinical Practices guidelines.
- Working knowledge of FDA and EMEA regulatory requirements for the development and licensure of new biological products.
- Understanding of the process and requirements for WHO prequalification of vaccines.
- Knowledge of biological formulation processes and manufacturing procedures.
- Demonstrated ability to work in a multi-site team-based organizational structure, including partners and other collaborators.
- Demonstrated ability to work with partners to achieve results.
- Fluency in English.
- Available to travel nationally and internationally up to 25 percent.
- Experience working in developing country settings desirable.
Doctor of Medicine (M.D.) with at least 10 years' experience in biologics research and vaccine development in industry, government, academia or other suitable organizations required.
Must have legal authorization to work in the United States.
PATH is dedicated to diversity and is an equal opportunity employer.
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