Job Type






Director, Toxicology Cambridge

Skills Alliance

Skills Alliance Cambridge United Kingdom

3 months ago

Director, Non-Clinical Safety / Toxicology

Location: Cambridge, UK

Do you want to play a leading role within a profit-making biotech? This company has a large portfolio of preclinical and clinical assets and has a long-term plan for success. The opportunity is to lead Toxicology activity within an experienced non-clinical department. You will be overseeing three external consultants who support with project work and study monitoring.


To provide scientific design, operational delivery and interpretation of toxicology studies required for drug candidates obtained via internal drug discovery or from in-licensing activities.

To provide expert understanding of evolving methodologies in the assessment of drug toxicity and their application to development.

Objectives and Responsibilities:
• To be the Toxicology Project representative and lead the scientific and operational design, execution and interpretation of non-clinical safety activity across discovery and into clinical... development.
• Investigate and understands relevant issues in determining the safety impacts of drug compounds with novel pharmacology.
• Engage with project teams and pharmacology to assist the prediction, interpretation and impact of PKPD modelling, toxicology findings, arising in nonclinical toxicology studies.
• Work with Discovery to build the project appropriate screening cascade for the detection of possible safety risks of potential discovery candidates.
• Engage with other Preclinical Development colleagues, CROs and external experts regarding the conduct and interpretation of both regulatory and bespoke nonclinical safety studies.
• Ensure CROs are identified, selected and proactively managed, including GLP compliance, to meet the company’s objectives.
• Authoring and reviewing of toxicology sections of Regulatory documentation.
• Pre-candidate selection: play an active role within project teams, during the candidate selection phase of lead optimisation projects to ensure the best molecules are selected for clinical development.
• Maintain awareness and application of Regulatory requirements relating to nonclinical toxicology studies.
• Develop realistic budgets for the toxicology element of development programmes to achieve the required project plan
• Work closely with Clinical Project Leaders to assess progress against plans and budget.

• PhD is ideal, with a minimum of 5 years working in non-clinical safety, ideally with significant project representative experience.
• Experience designing nonclinical safety strategies for projects from candidate nomination to Phase I
• Experience running and managing studies via external collaborators/CROs
• Experience interpreting and integrating the relevant data into project teams
• Excellent understanding of drug development, regulatory principles and clinical development requirements including GLP and 3Rs.
• Experience in writing regulatory documentation and answering regulatory questions

Next steps:

If you are interested in joining a world class R&D team, in a dynamic biotech located in one of the UK's leading biotech hubs, feel free to apply here or reach out directly.

For more information, contact Matthew Palmer @ Skills Alliance

[email protected]

+44 (0) 20 7220 6220

+44 7588125088

To schedule a confidential call:
Cambridge UK

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