ViiV Healthcare (GSK) Director/Toxicology Project Specialist

Key Responsibilities

• Toxicology project team member (PTM) supporting 5-10 projects at any given time
• Sufficient breadth of knowledge of all areas of NCS (and supportive processes) to strategically and efficiently drive aspects of projects in discovery and/or development phases, including provision for external diligence activities
• Has a good knowledge of other disciplines (e.g. Pharmacology, DMPK, Clinical, etc.) to enable visible contributions to a multi-disciplinary scientific/operational strategy
• Sustained ability to support multiple projects across various modalities, including small molecules, biologics and alternative platforms
• Proven competency to integrate data and craft clear and appropriate narratives for internal governance decision reviews e.g., technical/investment boards, and/or regulatory documentation (IB/IND/NDA/BLA)
• Proven excellent communicator (both written and verbal skills) which supports the capability to positively influencing external stakeholders, e.g. regulators (at a project level) or senior leaders in ViiV/GSK
• Coaches/mentors other project team members and is highly regarded as a reviewer/approver of regulatory and or internal milestone documents
• Sustained record of highly effective teamwork leveraging SMEs as required, providing clear and regular line of sight and leadership to project issues and progression challenges
• Leadership of major scientific or technical initiatives within and external to the Pre-clinical Sciences team
• Record of flexible, creative and courageous thinking, providing multiple options to project teams, EDLs/MDLs, etc.
• Ability to effectively prioritise multiple and conflicting objectives and evidence of learning agility
• Collaborate internally with GSK pre-clinical sciences organization and externally with academic institutions to leverage and enhance scientific capabilities
• Participate on due diligence teams in the integrated scientific/technical evaluation of external opportunities
• Contribute to consultancy on drug disposition, pre-clinical safety and on-target and off-target engagement/modulation on request, including support for marketed products, as needed
• Contribute to training and mentoring of other toxicologists, as appropriate
• Participate in internal and external committees and panels as assigned by the team leader

Basic Qualifications

• Master's degree with 8+ years, or PhD with 6+ years, of experience in non-clinical safety/toxicology
• Experience as a project team member covering a number of projects across a broad range of stages in development and across all modalities, including biologics
• Non-clinical Safety capability and experience coupled with an understanding of the interrelationships between disposition, safety and on/off target engagement as applied to the identification and articulation of critical needs and deliverables for projects
• Knowledge and experience of the Non-clinical Safety aspects of worldwide regulatory requirements for drug development and registration

Preferred Qualifications

• Experience in non-clinical discovery and development of long-acting small molecules
• DABT (Diplomat of American Board of Toxicology)
• Experience in infectious disease therapy area
• May be a recognized leader in a specific scientific field or discipline of interest, maintaining an extensive network (with a publication record) in that specific scientific field