Head Vaccine Toxicology

**Site Name**: USA - Maryland - Rockville, Belgium-Rixensart, Italy - Siena

**Posted Date**: Jan 27 2023

**Head Vaccine Toxicology**:

- Are you looking for an opportunity to design and lead Toxicology strategies and programs on new drug substances? If so, this is the job for you._

**Job Purpose**

As Toxicology Director you will provide specialized scientific (biology, physiology, pathology, surgical, cardiology, etc), veterinary, and translational expertise for drug discovery and development.

You will:

- Be the single point of accountability for toxicology deliverables supporting the vaccine pipepline throughout Research and Development
- Design, supervise and interpret toxicity studies meeting project team (PT) & regulatory (RA) requirements, in line with Tox WG guidelines
- Design, supervise and interpret investigative/mechanistic studies with potential metabolic/kinetic or toxicity endpoints meeting PT objectives
- Ensure revision of critical toxicological risk assessments related to quality/manufacturing events including but not limited to, extractables and leachable, impurities, excipients
- Provision of non-clinical toxicology input to Global Safety Board (GSB)
- Review of published reports (publications) concerning vaccine, adjuvant and/or excipient toxicity to determine relevance to risk-benefit profile of GSK Vaccines portfolio

**Your Responsibilities**

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

- Ensure appropriate staff are assigned to conduct and/or supervise studies in accordance with the study protocol and all applicable laws and regulations including, but not limited to, Good Laboratory Practices, Institutional Animal Care and Use Committee guidelines, and Standard Operating Procedures (as applicable).
- Ensure scientific excellence in Vaccines Toxicology, externally recognized thought leadership in the field, insight into current trends in Regulatory and Toxicology thinking.
- Establish best practices in Toxicology; ensures a program of training/mentoring/compliance of technical staff on laboratory procedures and that standard operating procedures (SOPs) and relevant training materials are in place
- Design, implement and execute a coordinated global strategy to deliver toxicology support for R&D Projects through standard and bespoke work packages investigating human-relevant target organ risks. The work includes planning, conducting and interpreting findings from preclinical studies, integration of drug disposition information and advising on safety hazard/risk assessment and plans to mitigate those risks.
- Contribute to design of studies and protocol review
- Define, refine, and implement standards and peer review to ensure data and appropriate reports are of high quality, meet GLP requirements, and build confidence in GSK’s integrity and scientific credibility with internal partners, external reviewers and Regulatory Authorities
- Implement and maintain strategic workforce planning to define project demand
- workforce capacity analysis in order to enable a responsive, capable workforce
- Optimize cycle times and costs for both internal and CRO toxicology work packages and establish a global process to monitor the efficiency of how and where work packages are completed.
- Learn from historical data to identify critical insights that lead to innovation of toxicology strategies and designs.
- Promote external networks and influence through key industry groups, scientific consortia and associated regulatory activities in the specialized safety testing area.
- Ensure development of scientists to maintain a highly motivated, productive and innovative science platform that builds on best practices across sites and related-disciplines to continuously improve toxicology strategies and tactics.
- As a member of the Non-Clinical Safety Leadership Team, make a full contribution to resolving operational issues and to the development of future NCS strategy and its implementation.
- Maintain a safe work environment consistent with local GSK
- Ensure scientific data and reports are reviewed for accuracy and quality
- Ensure compliance with GSK Values, SOPs and Policies, GLP, and data integrity, safety and animal welfare guidelines

**_ Why you?_**

**Basic Qualifications**

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

- PhD, Master (University Degree)
- Life Science (molecular, biology, vaccinology, immunology, infectious disease), pharmacy
- To be able to understand and lead the toxicology strategy that supports the pipeline development of existing or new vaccine assets.
- To master by education the minimum level of expertise required and to provide scientific oversight
- Present a good balance between scientific credibility and business acumen, but scientific credibility is the more critical. Credibility within external and internal expert communities