Sr. Toxicologist

Posted 28 September by GSK
Site Name: UK - Surrey - Weybridge, USA - New Jersey - Warren
Posted Date: Sep 21 2020

The purpose of the Sr. Toxicologist 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 Sr. Toxicologist 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 Category, Category Medical, Regional Medical, Clinical Development and GSK Pharma teams, as well as external groups and individuals, such as Trade Associations, Academic researchers, Contract Research Organizations, 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, different Regions and LOCs with complex governance and business expectations:

  • Escalation of all toxicology issues affecting the GSKCH business to Toxicology Director, ensuring 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.
  • 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.
  • Assist in the management of project-related spend

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

  • Participate in project teams and provide expert toxicology input to category/sub-category or local project teams
  • Including 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.
  • Preparation of expert toxicological documentation to support regulatory submissions (medicinal CTDs, cosmetic dossiers, medical device technical files, periodic update reports, responses to regulatory authorities and safety assessment) 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 and to include medical assessments in support of product quality investigations.
  • Preparation of expert toxicological documentation for the Consumer Healthcare Safety and Labeling Committee (CHSLC) and participation in discussions at CHSLC.
  • Recommend and agree with Toxicology Director studies at approved contract research organizations to provide high quality data to agreed timings and within budget constraints in support of specific projects.
  • 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 Principle Toxicologist/Toxicology Director on programs of toxicology studies for specific compounds intended to fill gaps in knowledge to support Clinical and Regulatory departments.
  • Monitoring of toxicology studies
  • 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:

  • Master's Degree in Toxicology, Pre-clinical Pharmacology or related study
  • 3 plus years of experience in preclinical pharmacology and toxicology in the CRO or pharmaceutical industry.
  • Expertise in assay development, ADME, preclinical pharmacology and toxicology.
  • Experience and Knowledge of cosmetic development requirements, medical devices and drugs will be an advantage.
  • Proven track record of research ability and independent academic thought is required.
  • Basic competency in management of all major types of regulatory toxicology studies, particularly a detailed knowledge of the principles of in vitro toxicology and a strong understanding of the cosmetics/drug development process is critical. Experience with specific product categories and/or therapeutic areas is a plus.
  • Knowledge and experience of preclinical data requirements and regulatory guidelines (EU and rest of the world Cosmetic Directives) would be preferred.
  • Proven experience in preclinical toxicology. Proven ability to manage preclinical studies.Well-organized, able to review and monitor work conducted by o
  • Reference: 40936837

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