ViiV Healthcare (GSK) Director/Toxicology Project Specialist

GSK•Durham, NC

4d•$162,000 - $297,000•Hybrid

About The Position

ViiV Healthcare is a global specialty HIV company dedicated to researching and delivering new medicines for people living with, and at risk of, HIV. The company is mission-driven, aiming to be a trusted partner in HIV education and treatment. ViiV focuses on delivering breakthroughs in treatments, care solutions, and community support, taking a holistic approach to HIV by developing and supporting sustainable community programs and improving access to care. The company is committed to eradicating HIV/AIDS and has been instrumental in making HIV a manageable health condition, offering a broad portfolio of HIV medicines. The work culture is described as fast-paced, diverse, inclusive, competitive, and caring, fostering a sense of belonging and encouraging employees to bring their best. This is an exciting time at ViiV as they evaluate novel approaches to treatment and prevention. This role will be based out of Upper Providence, PA or Branford, CT or Boston, MA or Durham, NC and is eligible for a domestic relocation package.

Requirements

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.

Nice To Haves

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.

Responsibilities

Developing the end-to-end non-clinical safety strategy for projects across ViiV Healthcare’s portfolio.
Working in a highly matrixed global environment and collaborating extensively to evolve non-clinical safety strategies based on input from market research, competitive intelligence, and learnings from internal programs.
Integrating non-clinical project plans with CMC, regulatory, and clinical plans to optimize speed of drug development.
Serving as a Toxicology Project Team Member (PTM) supporting 5-10 projects at any given time.
Strategically and efficiently driving aspects of projects in discovery and/or development phases, including provision for external diligence activities, with a breadth of knowledge in all areas of Non-Clinical Safety (NCS) and supportive processes.
Making visible contributions to a multi-disciplinary scientific/operational strategy by having a good knowledge of other disciplines (e.g., Pharmacology, DMPK, Clinical, etc.).
Supporting multiple projects across various modalities, including small molecules, biologics, and alternative platforms.
Integrating data and crafting clear and appropriate narratives for internal governance decision reviews (e.g., technical/investment boards) and/or regulatory documentation (IB/IND/NDA/BLA).
Communicating effectively (both written and verbal skills) to positively influence external stakeholders, such as regulators or senior leaders.
Coaching/mentoring other project team members and being a reviewer/approver of regulatory and/or internal milestone documents.
Demonstrating effective teamwork, leveraging SMEs as required, and providing clear leadership to project issues and progression challenges.
Leading major scientific or technical initiatives within and external to the Pre-clinical Sciences team.
Providing multiple options to project teams, EDLs/MDLs, etc., through flexible, creative, and courageous thinking.
Effectively prioritizing multiple and conflicting objectives and demonstrating learning agility.
Collaborating internally with GSK pre-clinical sciences organization and externally with academic institutions to leverage and enhance scientific capabilities.
Participating on due diligence teams in the integrated scientific/technical evaluation of external opportunities.
Contributing to consultancy on drug disposition, pre-clinical safety, and on-target and off-target engagement/modulation, including support for marketed products, as needed.
Contributing to training and mentoring of other toxicologists, as appropriate.
Participating in internal and external committees and panels as assigned by the team leader.