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.

Summary:

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.

Requirements:
• 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: https://calendly.com/matthew-palmer-/30min
Cambridge UK

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