ViiV Healthcare (GSK) Director/Toxicology Project Specialist

GSK; Upper Providence (Delaware County); Hybrid; USD 162,000 - 270,000; Full time

Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Job summary

ViiV Healthcare is seeking a Director/Toxicology Project Specialist to shape non-clinical safety strategies across multiple projects in a global matrixed environment. The role integrates input from market research, regulatory and internal programs to optimize drug development timelines, with leadership across discovery and development phases.

You will mentor other toxicologists, coordinate with SMEs, and contribute to governance reviews and external collaborations while driving strategic

Qualifications

• Master’s degree with 8+ years, or PhD with 6+ years in non-clinical safety/toxicology.
• Experience across multiple projects and modalities including biologics.
• Knowledge of worldwide regulatory requirements for non-clinical safety.

Responsibilities

• Develop end-to-end non-clinical safety strategy for projects.
• Lead toxicology project team members and coordinate with DMPK, Pharmacology, Clinical teams.
• Integrate non-clinical plans with CMC, regulatory and clinical timelines.

Skills

Biotech knowledge

Project leadership

Cross-functional teamwork

Drug development

Scientific writing

Communication

Education

Master’s degree or PhD in a related field

Job description

ViiV Healthcare

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.

Director/Toxicology Project Specialist

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:

• 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.

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

Salary and benefits

• Annual base salary for new hires in this position ranges $178,200 to $297,000 for Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA.
• Annual base salary range is $162,000 to $270,000 for other US locations.

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.

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.

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.

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

Why GSK?

Unifying science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do – from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we’re all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.