Senior Toxicology Manager - Cambridge
Jason at CK Science is recruiting for a Senior Toxicology Manager / Head of Toxicology Department to take on a key and largely autonomous position with a world leader in drug discovery and development. The company are determined to make a positive impact on the lives of patients suffering from serious disease including neurodegeneration, mitochondria diseases, cancer and inflammation. This is a permanent role based in Cambridge and offers a competitive salary, a strong benefits package and the opportunity to have a direct and meaningful affect on patient's lives.
The Company: Having already received over $100 million in venture capital from a blue chip syndicate and a recent collaboration with an extremely well established discovery/development group they are quickly establishing their own widely-applicable and proprietary research platform to enable the discovery of first in class drugs. With facilities based in Cambridge, the heart of Europe's largest biotechnology cluster and several projects progressing rapidly this is an ideal time to make the move to join them.
The Role: The Head of Toxicology will contribute to the optimization of new chemical series and selection of novel candidate drugs. They will be responsible for the non-clinical safety support of all development programs at the company, with a particular focus on toxicology project support. Core responsibilities include non-clinical safety plans for development programs, and toxicology/safety pharmacology study design and oversight in support of INDs, data interpretation and presentation, as well as preparation and review of non-clinical safety related regulatory documents and submissions.
- Providing nonclinical toxicology and safety support to company projects.
- Designing and implementing project specific in vitro and in vivo strategies to predict, assess and mitigate target and compound related safety risks.
- Leading development and execution of non-clinical safety drug development plans for novel therapeutics in accordance with appropriate ICH, FDA, and EMA guidelines.
- Responsible for oversight of conduct of GLP safety packages supporting preclinical development programs.
- Responsible for timelines, CRO selection, contract negotiations, protocol preparation and review, study conduct, report preparation, report review and finalisation.
- Designing and dosing selection for GLP and non-GLP toxicology/safety pharmacology studies.
- Contracting and study monitoring GLP and non-GLP toxicology/safety pharmacology studies.
- Preparing and/or reviewing nonclinical safety portions of IND submissions, briefing packages for regulatory meetings and investigator brochures.
- Integrating findings from pharmacology, clinical pharmacology, DMPK, toxicokinetic and toxicology studies to project margins of safety.
- Awareness of PKPD approaches and application to safety risk assessment.
- You will hold a PhD-level qualification (or equivalent experience) in pharmacology, toxicology, pathology or a related scientific discipline.
- Several years experience gained in a pharma/biotech/CRO non-clinical safety environment.
- Demonstrated ability to provide innovative solutions to safety and toxicological issues/risks.
- Highly autonomous and able to work independently.
For more information or to apply for this Senior Toxicology position, please contact Jason Johal on 01438 723 500 or email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44381 in all correspondence.