Global Head Nonclinical Safety, ViiV

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Site Name: Durham Blackwell Street, GSK HQ, USA - Connecticut - Branford, USA - Pennsylvania - Upper Providence
Posted Date: Mar

Job Purpose:
The Vice President of Non-Clinical Safety and DMPK is pivotal in safeguarding the safety of ViiV drugs from Discovery through Development and into the post-marketing phase. This role is essential in providing the safety foundation for clinical trials by ensuring the delivery of appropriate toxicology and DMPK packages. These efforts are crucial for understanding exposure and dose targets, clinical monitoring, and forming a critical component of regulatory and other submissions throughout the drug's lifecycle. The VP of Non-Clinical Safety and DMPK is responsible for the strategy and decisions around nonclinical safety, ensuring rigorous oversight within ViiV and in collaboration with GSK. As a core member of the VSLC, this role is integral in delivering a clear and transparent toxicology narrative and risk assessment, thereby significantly contributing to the success and safety of the ViiV portfolio.

Job Responsibilities:

• Design non-clinical safety evaluation strategies: provide comprehensive toxicological interpretations in support of the global development and registration of drug candidates.
• Serve as non-clinical safety and DMPK expert to program and project teams: coordinate non-clinical safety support across all projects in the portfolio from early discovery to marketed projects.
• Leadership and liaison role: facilitate strong partnerships and efficient resource use between ViiV and GSK non-clinical lines to ensure strategic understanding and delivery on ViiV projects.
• Non-clinical review and support: Responsible for non-clinical review forums and nonclinical safety support on technical due diligence.
• Expert advice at key committees: Provide nonclinical safety expertise at ViiV Safety and Labelling Committee and other scientific and management meetings.
• Manage non-clinical delivery for ViiV portfolio: Ensure the delivery of non-clinical data to support the ViiV portfolio and collaborate with GSK staff on nonclinical study delivery, safety, and DMPK issues.
• Provide non-clinical safety and DMPK support to marketed products: Provide non-clinical safety support, review and technical approval for annual reports, literature searches, DSURs, regulatory questions, and more.
• Active member of Early Development Committee: Align non-clinical strategies with business objectives to ensure the successful delivery of the early development pipeline.
• Documentation and representation: Prepare, oversee, review, and present non-clinical safety evaluation information for internal purposes and regulatory authorities.
• Manage ViiV Toxicology and DMPK team: Align strategy and deliverables to identify and progress high-quality candidate compounds, mentor, develop ViiV team and provide matrix management to GSK team members supporting the ViiV portfolio.

Basic Qualifications

• Life Science Degree with post graduate Masters or PhD.
• Experience of working in the HIV therapeutic area.
• Experience in non-clinical development including post-marketing life cycle management.
• Leadership experience in a matrix environment.
• Knowledge of running non-clinical studies to support various stages of clinical development.
• Effective communication skills.
• Good interpersonal relationship building/maintenance.

Why Us?
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.