Senior Toxicologist - All Genders

Hello . We ’ re Haleon . A new world-leading consumer health company. Shaped by all who join us. Together, we ’ re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin , and Centrum – through a unique combination of deep human understanding and trusted science. What ’ s more, we ’ re achieving it in a company that we ’ re in control of. In an environment that we ’ re co-creating. And a culture that ’ s uniquely ours.

Care to join us. It isn ’ t a question.

About the role:

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 Haleon (HLN) 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 HLN products. Interacting with internal teams, such as R&D Category, Business Units, Clinical Development, 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 HLN reputation.

The role will have accountability for and oversight of the following activities with the complexity of multiple stakeholders, different Regions and Local Operating Companies with complex governance and business expectations:

• Escalation of all toxicology issues affecting the HLN business to Toxicology Director
  • Ensures effective and timely communication of key safety issues, scientific information and risk assessments for those categories/ sub-categories they have responsibility
• Implement planning, monitoring and reporting of toxicology studies.
• Support the implementation and compliance of the corporate animal testing policy and associated HLN 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 HLN business on key industry initiatives related to toxicology and/or animal welfare issues. Specifically Trade Association groups (e.g. 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

Key Responsibilities :

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 updatereports, responses to regulatory authorities and safety assessment) for new and existing HLN 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 Haleon Safety Board (HSB) and participation in discussions at HSB.
• Recommend and agree with Director Toxicology Worldwide 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 HLN products marketed to the public.

Contribute to the design and agree with Associate Toxicology Director / Director Toxicology Worldwide 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 HLN test articles to be used in human subject testing.

Knowledge/ Education / Experience :

• Doctorate level degree or Medically qualified, specialized in Toxicology, Pre-clinical Pharmacology
• 3 plus years of experience in toxicology or preclinical pharmacology in CRO, consumer healthcare or pharmaceutical industry. Expertise in impurity assessments, assay development, and toxicology.
• 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 medical devices and/or therapeutic areas is a plus.
• Well-organized, able to review and monitor work conducted by others, especially at contractors/partners.

Your skills:

• Knowledge of cosmetic development requirements, medical devices and drugs will be an advantage.
• Registered Toxicologist in the EU and/or Diplomate of the American Board of Toxicology.
• Strong problem-solving skills with the ability to think outside-the-box.
• Good time management, IT skills, and planning.
• Excellent written, oral communication skills. Ability to communicate through all levels of the organization.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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Haleon is an Equal Opportunity Employer. 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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