Job Title: Senior Director, Early Development
Location : DDL
Position Summary :
The International AIDS Vaccine Initiative (IAVI) is a global, not-for-profit, public-private partnership organization working to speed the search for a vaccine to prevent HIV infection and AIDS. Founded in 1996 and operational in 24 countries, IAVI, and its network of partners, research and develop vaccine candidates. IAVI also advocates for a vaccine to be a global priority and works to ensure that a future vaccine will be accessible to all who need it.
IAVI carries out its research objective through extensive partnerships along with in-house research. IAVI and partners are engaged in a multi-year, multi-million dollar effort to discover HIV vaccine candidates that elicit broadly neutralizing antibodies and/or are based on replicating viral vectors. This discovery process is nearing fruition as several vaccine candidates will soon emerge from the research laboratory to advance toward clinical testing.
At this time, IAVI needs to develop the core expertise of preparing vaccine candidates under GMP conditions. To address this need , IAVI plans to hire an experienced individual to establish an Early Development capability to speed the transition of IAVI sponsored projects from Vaccine Design to Vaccine Development, and potentially to do the same for IAVI partners and the greater HIV vaccine field.
The Senior Director, Early Development (SDED) will be responsible for assuring the rapid and efficient transition of promising clinical vaccine candidates to GMP manufacture and clinical testing, and to this end, the Early Development function will identify and test the methods required for GMP. The SDED will work closely with discovery groups to assure that sophisticated designs of vaccine candidate are preserved in the GMP product. The successful SDED candidate must have the expertise required to understand the vaccine product in detail
Within IAVI’s strategy of managed outsourcing, much of this work will be accomplished through contract research organizations (CROs). The successful SDED candidate will also have experience and expertise identifying and supervising appropriate CROs. The SDED will also direct internal research staff in the experimentation needed to ensure the success of contract research.
The SDED will be responsible for the following four areas:
- Participate in specific Vaccine Design and Development teams focused on advancing particular vaccine candidates in the transition from research to clinical development. Depending on the stage of such projects, he/she may lead such teams focused on the establishment of processes suitable for transfer to the IAVI Development group.
- Serve as the primary point of contact with collaborators for all science pertaining to transitioning from research to development level processes.
- Interface with partners who wish to use IAVI capabilities to transition their vaccine candidates from research to development. This will require an efficient and transparent working relationship with such partners.
- Responsible for instituting and leading the IAVI capabilities that enable the Early Development of vaccine candidates.
- Identify external CROs to develop GMP processes for cell line development, vaccine production process development, analytical characterization and stability testing.
- Institute systems suitable for the supervision of CROs.
- Propose additional capabilities needed by IAVI to execute Early Development functions.
- Determine the exact strategy for internal capabilities to allow for detailed understanding of the vaccine product characteristics and enable IAVI to more easily direct and verify the work of contractors.
- Develop a highly synergistic and collaborative interaction with the IAVI Development group particularly those in place to manage GMP production and testing as well as QA, regulatory and project management. Such collaborative interactions will also be required with extramural partners with research and development expertise will develop a close working relationship with the IAVI Development group and extramural partner groups conducting discovery research as well as development functions.
Resource Mobilization responsibilities:
- Assist in the preparation of donor and grant applications as well as project reporting.
- Presentation of IAVI R&D efforts and results internally and externally including but not limited to
- Presentations at Scientific Meetings
- Media and public contact
- The SDED will work closely with the staff of Vaccine Design and Vaccine Development to assure implementation of plans and efficient use of IAVI resources.
- The SDED will work closely with Project Managers to assure alignment between the scientific goals of the projects the corresponding project plans, and related budgets.
Experience and Skills :
- Must have an PhD, MD or equivalent degree
- Extensive knowledge of experimental and early clinical phase biological products particularly those based on mammalian cell derived proteins and viruses.
- Experience with the establishment of cell lines for use in GMP production of biological compounds.
- Experience with establishing process for the GMP production of biological compounds including the upstream production employing mammalian cell culture, the purification of proteins and virus particles.
- Experience with establishing the required methods and procedures to determine the quality testing of biological products.
- Experience with formulation and stability testing of biological products.
- Experience with development of analytical methods for the evaluation of protein products.
- Experience with the role of Quality Assurance in the development of process for biological product candidates.
- Experience working with external partners who wish to advance a biological candidate.
- Commitment to IAVI’s mission
- Excellent verbal and written communication skills.
Salary: Commensurate with experience