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 Responsible for reducing attrition by supporting efforts to identify the best candidate vaccines/adjuvant or combination, timely project issue resolution, and clinical translation of in vitro/ex vivo data by working in partnership with the Research and the In Vitro/In Vivo laboratory function heads. 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 Job experience: Leadership capability – demonstrated ability to lead and inspire teams, and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities Strategic Thinking – maintain competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems Business Acumen – Understand the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D Project Management – Demonstrate the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics Preferred Qualifications If you have the following characteristics, it would be a plus: PhD (University Degree) with scientific track records and certifications in Toxicology Veterinary & toxicology track recordS Leadership in cross-functional teams - credibility within the organization, especially in the interactions with VDLs, CRDLS, Preclinical heads &, safety board Credibility outside the organization when interacting with regulatory agencies & external collaborators Ability to follow rapid technological evolutions and to zoom in/zoom out when consolidating different pieces of evidence to address safety problem Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.