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.  

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• 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.

 Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 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:

If you have the following characteristics, it would be a plus:

• 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.

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Skills

Biotechnology, Business Strategies, Cell Biology, Cross-Functional Teamwork, Drug Development, Drug Discovery Process, Influencing Without Authority, Interpersonal Communication, Life Science, Market Opportunities, Matrix Leadership, Molecular Biology, Scientific Research, Scientific Writing, Strategic Alignment

 

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $178,200 to $297,000. • If you are based in another US location, the annual base salary range is $162,000 to $270,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.