ViiV Healthcare (GSK) Director/Toxicology Project Specialist

GSK•Boston, PA

3d•Hybrid

About The Position

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic. We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn’t just somewhere to work – it’s a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference. While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. This role will be based out of Upper Providence, PA or Branford, CT or Boston, MA or Durham, NC & is eligible for a domestic relocation package. As the Director/Toxicology Project Specialist , you will be responsible for developing the end-to-end non-clinical safety strategy for projects across ViiV Healthcare’s portfolio. You will work in a highly matrixed global environment and collaborate extensively to evolve non-clinical safety strategies based on input from market research, competitive intelligence, and learnings from internal programs. You will also work to integrate non-clinical project plans with CMC, regulatory, and clinical plans to optimize speed of drug development.

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

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.