Head of Preclinical Toxicology
Site Name: USA - Maryland - Rockville Posted Date: May 7 2021 Does the prospect of leading global toxicology strategies and partnering with cross-functional R&D teams excite you? Do you thrive in a highly collaborative, global, matrixed environment? If so, then read on for an exciting opportunity within GSK Vaccines' Preclinical R&D team! With a portfolio of more than 40 vaccines for every stage of life that protect people against 22 different diseases, GSK's vaccines business delivers nearly 2 million vaccines every day in over 150 countries around the globe. Our vision is to lead vaccine innovation by bringing novel vaccines to market and applying our cutting-edge technologies - such as our self-amplifying messenger RNA - to help shorten the vaccine manufacturing process and boost immunogenicity. To help make this vision a reality, GSK opened the Rockville Center for Vaccines Research in 2015 in Rockville, MD. This state-of-the-art facility is GSK's global vaccine R&D center in the US and is home to more than 400 employees across multiple global functions. The Rockville Center is the R&D hub for several candidate vaccines in development, including therapeutic vaccines for chronic disorders, as well as the commercial and life cycle management hub for GSK's seasonal influenza, meningitis and zoster vaccines. Due to continued growth, the Preclinical R&D team in Rockville is hiring for a Head of Preclinical Toxicology to lead the safety assessments of vaccines in R&D programs and GLP toxicology studies. This individual will provide nonclinical safety guidance to co-located project teams and will serve on the Toxicology Working Group and be an active member of the US Preclinical Leadership team. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Toxicology in-house expert providing nonclinical safety input to co-located project teams in Technical Development, Preclinical, Clinical, Medical Affairs, Regulatory, Global Patents, Legal, and Business Development departments. Provide input on commercial products and regulatory documents (CTD, IND, CTA, PSUR/DSUR, Q&A, etc.) needed during vaccine development, for new submissions, and during product lifecycle Design, place, and monitor preclinical toxicity studies and finalize associated reports for US projects that will allow the clinical trials and/or worldwide registration file submissions. The work contracted-out in GLP laboratories should be performed in compliance with the international guidelines (e.g. EMEA/CBER/ICH/WHO), good laboratory practices (GLP, OECD, ICH), and GSK Vaccines guidelines & policies, as applicable. Budgetary oversight through the management of study costs, departmental budgets and invoicing. Lead and participate in discussions with regulatory authorities across the globe in all matters pertaining to nonclinical toxicology for GSK Vaccines products Ensure high scientific and regulatory standards of non-clinical toxicology documents submitted to regulatory authorities worldwide and/or to GSK governing bodies. Ensure that expert advice in toxicology is provided in all matters where needed for the safety assessment and documentation of GSK's project and product portfolios Guide and mentor more junior toxicologists in all sites. Provide technical/scientific expertise and contribute to company and project decisions and recommendations related to the preclinical evaluation of vaccines such as feasibility of animal models (including animal handling and ethical issues), imaging, and/or pathological assessment. Serve as the Laboratory Animal Sciences representative for the PRD US department, leading a matrixed team of scientists outsourcing in vivo studies to 3rd party providers. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master's Degree in toxicology, pharmacology, or a closely related field of study 10+ years of experience covering different areas of toxicology for drugs, biologics, and preferably vaccines. Expertise in toxicology, pharmacology and preclinical safety, including guidelines, requirements and regulations, methodologies, and results interpretation & presentation. Knowledge of biology, infectious disease, biochemistry and immunology domains Experience with regulatory guidelines, legislation, registration procedures, and regulatory authorities Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD and Board certification in Toxicology, Laboratory Animal Sciences, or a related discipline DABT or other recognized Toxicology certification Expertise in manufacturing-related issues (E&Ls, impurities, cleaning validation, etc.) and toxicological and risk assessments of these issues Experience initiating and managing external collaborations Knowledge of related disciplines (chemistry, biology, drug metabolism/pharmacokinetics, safety and clinical study design) to enable multidisciplinary approaches Experience progressing projects through the drug discovery and development process. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK 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. 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