ViiV Healthcare

Director

• Develop end-to-end non-clinical safety strategies for projects across ViiV Healthcare’s portfolio
• Collaborate in a highly matrixed global environment to evolve non-clinical safety strategies using market research, competitive intelligence and internal program learnings
• Integrate non-clinical project plans with CMC, regulatory and clinical plans to optimize drug development speed
• Serve as toxicology project team member supporting 5–10 projects at a time
• Drive aspects of discovery and development projects across all areas of non-clinical safety and supportive processes
• Contribute to multidisciplinary scientific and operational strategies using knowledge of pharmacology, DMPK and clinical disciplines
• Support projects across small molecules, biologics and alternative platforms
• Integrate data and craft narratives for internal governance reviews and regulatory documents, including IB/IND/NDA/BLA
• Influence external stakeholders, including project-level regulators, and senior ViiV/GSK leaders
• Coach and mentor project team members
• Review and approve regulatory and internal milestone documents
• Lead major scientific or technical initiatives within and outside the Pre-clinical Sciences team
• Provide options and strategic thinking to project teams and EDLs/MDLs
• Prioritize multiple conflicting objectives and address project issues and progression challenges
• Collaborate with GSK pre-clinical sciences and academic institutions
• Participate in due diligence teams evaluating external opportunities
• Provide consultancy on drug disposition, pre-clinical safety and on-target/off-target engagement or modulation
• Contribute to training and mentoring toxicologists
• Participate in internal and external committees and panels as assigned

Director – Toxicology Project Specialist