Title:  Computational Toxicology Manager

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Learn more: jti.com

Computational Toxicology Manager

Position purpose:

The Computational Toxicologist performs  toxicological risk assessments of flavor substances, tobacco ingredients, NTM ingredients, packaging ingredients and other substances used in the manufacture of JTI products. In addition, the incumbent contributes to these toxicological risk assessments by developing and deploying state of the art in silico toxicological tools including scientific data handling approaches. In this context the incumbent is responsible for ensuring that global SRA business objectives, needs, and user requirements from SRA business units are transposed into systems developments, robust operational business processes and the associated maintenance thereof. The incumbent will ensure the scientific integrity of JTIs in silico toxicological tools, while testing and validating the tools in order to verify the correctness of scientific data handling, search engines, workflows and predictive models. The incumbent will be an integral part of the SRA digitalization initiative and ensures appropriate inclusion of in silico tools, closely interacting with, end users, IT BTS and the SRA Systems and Process Director, in the SRA digital landscape.

The incumbent supports the training activities of other relevant internal stakeholders and actively contributes to the external communication for example in publications, scientific conferences or in meetings with their expert network.

What will you do – responsibilities:

Risk assessment and in silico Data handling and analysis

Contribute to toxicological risk assessments of flavor substances, tobacco ingredients, NTM ingredients, packaging ingredients and other substances used in the manufacture of JTI products to ensure the scientific defensibility of products worldwide by developing and deploying state of the art in silico toxicological tools including scientific data handling approaches

Identify and process relevant safety datasets (internal and external/new and existing) and scientific resources. Propose and collaborate on the use of computational predictive methods to fill data gaps, employ evidence toolkits, and apply computational findings to aid Toxicologists in predicting safety outcomes. Adopt state-of-the-art, e.g., machine-learning methods and new approach methodologies (NAMs) to improve the biological interpretation and predictive value of such NAMs data in toxicology.

In Silico Tools and data handling – Development

Collaborate with Toxicologists, Researchers and Data Scientists to conceive computational analysis strategies including customized data, tools and system integration pipelines to support prediction of endpoints and combination of evidence to aid toxicological risk assessments. Specific applications can be but not limited to -omics, pharmacokinetics, in vitro and /or in vivo safety data, Adverse Outcome Pathway (AOP) analysis, molecular data integration, Integrated Approaches to Testing and Assessment (IATA) tools to fill the gap between evolving scientific research and regulatory assessment challenges. Affinity with Findable, Accessible, Interoperable and Reusable (FAIR) principles. Ensure appropriate documentation, continuous improvement, redundancy protocols and further development of existing tools to maintain state of the art in silico toxicological tools within JTI.

In Silico Tools and data handling - Support for Maintenance

Support with scientific knowledge IT BTS and SRA R&S to maintain and minimize downtime of deployed in silico solutions such as databases, pipelines, predictive models, and workflows.

SRA Digitalization

Partner with the SRA Systems and Process Director to develop and align a digitalization agenda to reinforce SRA digital landscape, aiming to integrate new and existing scientific data and computational methods to support pipeline programs and platform technology to ease end user adoption.

Contribute in the transition to NGRA, including handling and integration of NAMs data, acting as a Product Owner, mentoring, coaching toxicology team members, ensuring proper documentation and playing a key role in leveraging applied computational literacy within the team.

Product Compliance and External Engagement

Support toxicology team members in the evaluation strategies to meet regulatory requirements and submission deadlines. Perform expert assessments using toxicological prediction tools, but not limited to, cheminformatics, exposure modelling, bioinformatics, and advanced database searches. Communicate results efficiently and effectively ensuring appropriate documentation and filing of data and/or reports.

Represent JTI at meetings with external experts in the area of in silico toxicology. Actively contribute to publications, and  conferences. Closely monitor competitor activities and support the development of relevant company positions.

Risk assessment & Product Testing

Perform toxicological risk assessments of flavor substances, tobacco ingredients, NTM ingredients, packaging ingredients and other substances used in the manufacture of JTI products or third parties, to ensure the scientific integrity of JTI products worldwide.  Harmonize and standardize toxicological evaluation processes within JTI SRA function, to increase the efficiency of the toxicological review processes within the product stewardship program.                                                               

Commission the different tests required under the JTI toxicology program including liaison with contract research laboratories. Support the design and management of any JTI toxicological study.

Who are we looking for – requirements:

• University degree in Life Science, Chemistry, Toxicology, Cheminformatics, Bioinformatics or in a related field. Degree or PhD in toxicology as well as ERT (European Registered Toxicologist) or DABT (Diplomate of the American Board of Toxicology) certification is a plus.
• Proven knowledge or experience with toxicological risk assessment procedures, toxicological test strategies, statistical analysis and regulatory requirements (ICH, OECD, GLP, REACH). 3-5+ years relevant experience dealing with chemical structures and chemical data in academia or industry.
• Proven knowledge with emerging toxicological and risk assessment technologies, applied computational methods, exposure modeling, alternative in vitro exposure systems, etc.
• Experience with various computational toxicology approaches including, but not limited to predictive QSAR models for physical/chemical properties and human health toxicological endpoints, such as EPI Suite or the OECD QSAR Toolbox.
• Excellent English communication skills (both written and oral), further language skills would be an additional asset.
• Expertise in various computational toxicology approaches and data handling methods related to toxicological risk assessment in a regulatory context. Areas of computational toxicology expertise should cover hazard identification, dose-response assessment, exposure assessment and risk-characterization methods. Experience with data-driven research and tools in a regulated environment.
• High degree of flexibility, agility and motivation as well as good analytical skills and problem-solving mindset. Strong interpersonal skills with the ability to work both independently as well as cross-functionally in expert teams to support Next Generation Risk Assessment (NGRA).