Principal Toxicologist

Warren, NJ
September 30 2021
Organization Type
Site Name: USA - New Jersey - Warren Posted Date: Sep 30 2021 The purpose of this role is to contribute medical/scientific excellence and, as required, project-based leadership of Toxicology and associated nonclinical activities across the global GlaxoSmithKline Consumer Healthcare (GSKCH) organization. The role will serve as a resource of scientific excellence, dedicated to delivering professional high quality toxicological expertise to ensure the safety of all new and existing GSKCH products. Interacting with internal teams, such as Innovation, Medical, Regulatory, Clinical Development, Pharmacovigilance, as well as external groups and individuals, such as Trade Associations, Academic Researchers, Contract Research Organizations (CRO), Health Care Practitioners, Government Agencies and Health Care Organizations to help achieve company objectives and to build GSKCH reputation. The role will have accountability for and oversight of the following activities with the complexity of multiple stakeholders, as well as different Regions, with complex governance and business expectations: Escalation of all toxicology issues affecting GSKCH to the Toxicology Director Worldwide Ensure effective and timely communication of key safety issues, scientific information and risk assessments for those categories/ sub-categories for which they have responsibility Implement planning, monitoring, and reporting of toxicology studies Support the implementation and compliance of the corporate animal testing policy and associated GSKCH operating procedures in conduct of animal research Collate, summarize and interpret toxicological and other relevant data to be used either internally or to be submitted to regulatory authorities Prepare and/or provide critical scientific review of nonclinical Common Technical Documents (CTDs) for regulatory submission Represent and/or provide oversight for GSKCH business on key industry initiatives related to toxicology and/or animal welfare issues. Specifically Trade Association groups (e.g. CTPA, PCPC, CHPA, Cosmetics Europe) and industry alliances to provide expert advice in support of business interests and act as focal point for communication with relevant therapeutic categories/businesses. Manage project related spend Assist in the management and strategic leadership for outsourced vendors Key Responsibilities Participate in project teams and provide: Timely recommendations for toxicological assessments or testing, and advise project team of the impact that recommended actions will have on project timeline Advise on safety assessments of new and existing products in support of registration and marketing Expert toxicological documentation to support regulatory submissions (medicinal CTDs, cosmetic dossiers, medical device technical files, periodic update reports and responses to regulatory authorities) for new and existing GSKCH products on global markets as well as provide expert toxicological assessments/opinions to address internal and external issues raised on marketed products, to include medical assessments in support of product quality investigations Expert toxicological documentation for the Consumer Healthcare Safety and Labeling Committee (CHSLC) and participation in discussions at CHSLC Provide local Safety Reassurance as required, including the conduct and documentation of safety assessments of formulations/individual ingredients to determine the safety and regulatory compliance of GSKCH products marketed to the public Contribute to the design and agree with Toxicology Director Worldwide on programs of toxicology studies for specific compounds intended to fill gaps in knowledge to support Clinical and Regulatory departments: Monitor toxicology studies at approved contract research organizations to provide high quality data to agreed timings and within budget constraints in support of specific projects. Contribute to the interpretation and reporting of study results to project team Ensure team awareness as to the significance of results from toxicology studies and recommend consequential course of action to clarify issues relevant to project development. Evaluate, interpret and summarise toxicological data on product formulations or ingredients and make recommendations on its adequacy Ensure project specific work is carried out according to GLP/GMP/GCP standards as defined in the FDA, EU and ICH guidelines, thus assuring the manufacture and release of quality products for human use Be familiar with specific requirements of regulatory authorities for toxicological data on specific product/compound types in different therapeutic categories so as to be better able to offer advice and make recommendations to project/category management teams Provide Nonclinical and Toxicology expertise on potential licensed products (due diligence) Provision of Safety Reassurance to Ethics Committees and Institutional Review Board for GSKCH test articles to be used in human subject testing Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors Degree in Toxicology, Nonclinical Pharmacology · 5+ years of experience in toxicology in consumer product industry, pharmaceutical industry or CRO Experience in the preparation of nonclinical CTD modules for regulatory submission Experience with cosmetic, medical device, and medicinal product development requirements Experience in managing nonclinical studies, management of all major types of regulatory toxicology studies, principles of in-vitro toxicology and f cosmetic and drug development. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree or PhD in Toxicology, Nonclinical Pharmacology · Experience with specific product categories and/or therapeutic areas is a plus Knowledge and experience of nonclinical data requirements and regulatory guidelines. Experience with regulations in EU, US and China is a plus. Well organized, able to review and monitor work conducted by others, especially at contractors / partners. 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. 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