Conceive strategies, design, and direct the execution of vaccine discovery programs Lead team of Ph.D. scientists and research associates to execute and complete vaccine discovery project objectives Lead existing vaccine projects in pre-clinical and clinical development including development of lab-scale processes, analytical methods for vaccine characterization and preclinical and clinical immunogenicity and preclinical efficacy evaluation. Author scientific publications and reports to support regulatory filings. Establish and direct collaborative projects with other Takeda functions, academic and industry collaborators
- Lead discovery activities for one or more projects to develop candidate live-attenuated, inactivated, or recombinant vaccines through pre-clinical evaluation. Effectively manage a team of Ph.D. scientists and research associates, including promoting a speak up culture, recognizing team accomplishment and providing career development. Design program and lead team to execute complex vaccine development activities in support of regulatory filings for new vaccine candidates or those already in clinical development, including:
- Lab-scale processes for seed virus generation and antigen production. Analytical method development to quantitate potency and characterize vaccine components Immunogenicity and efficacy models and immune assays to quantify immune responses in pre-clinical studies. Novel immunogenicity and virology assays for exploratory clinical endpoints
- Analyze, interpret and summarize complex data and contribute to project decisions. Propose, establish and lead collaborative projects with academic and corporate collaborators or CROs. In collaboration with clinical development, design and execute R&D studies to characterize human clinical immune responses to candidate vaccines in development. Collaborate with serology, process development and CMC in the transfer of analytical methods and vaccine candidates. Contribute as Discovery representative on one or more Global Project Teams
- Present project strategies, plans, status and results in internal and external meetings and publications. Other duties as required.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Ph.D. in a scientific discipline with a minimum of 16 years vaccine development experience , MS in a scientific discipline with a minimum of 18 years vaccine development experience, or a BS in a scientific discipline with a minimum of 20 years vaccine development experience.
- Proven ability to design and develop viral vaccines, including scientific accomplishment in virology, molecular biology, immunology or related field.
- Scientific management experience, including demonstrated experience managing laboratory personnel in a team environment and a working knowledge of scientific project management.
- Significant industry experience and working knowledge of GLP practices.
- Well connected in the vaccine research and development field, with proven track record of establishing and managing collaborative projects.
- Exemplary oral and written communication skillsCompliance with Takeda safety practices and standard operating procedures.
- Exhibit and promote Takeda Core Competencies.
- Comply with institutional certifications and requirements in a BSL-2 environment, including shipping regulations for infectious agents.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical office and laboratory bending, stooping, lifting requirements apply.
- Position requires up to 25% travel
- International travel will be required
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