about the company.
Client's R&D projects will focus on prophylactic and theopoetic vaccine candidates against AMR bacterial infection which is taking proactive action to grow its project pipeline and the incumbent will be an important part of developing a long-term pipeline strategy, developing new project opportunities and project execution.
about the job.
Program and Technical Responsibilities
• Manage aspects of vaccine (and other pipeline) candidates’ evaluation, including in vivo and in vitro preclinical studies to support vaccine immunogenicity and efficacy.
• Support all product specific bioanalytical method development, animal model development and sample test on study protocol preparation, data analysis and study report submission.
• In conjunction with the R&D team, support the overall product development strategy with a focus on regulatory compliance
• Provide technical input on regulatory strategies and applications, including taking the lead on some preclinical aspects
• Drive the implementation of best practices for Delonix’s immunology team
• Support funding applications
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• Proactively identify issues in product development and assist in providing concrete, plausible solutions.
Collaboration/Partner Management
• Coordinate with the CSO and R&D team to provide expertise and scientific direction across cross-functional teams
• Identify and manage outside contractors as appropriate
• Oversee data analysis and prepare or review the protocols and final reports for studies conducted by third parties
• Support all cross-functional needs (regulatory, quality, CMC, project management, operations, finance, etc.)
skills and experience required.
•Advanced scientific degree (PhD, PharmD, MD or MS) required.
•Minimum 4 years in Pharma/Biotech industry.
•Prior 3rd party medical communication agency experience is preferred.
•Proficient level of understanding in drug development process, pharmaceutical business, including R & D process & objectives.
•Demonstrate ability to drive and implement strategy in own area and work closely with other areas of the business