Overview
Reference Number: JO-2306-517335
Director of Toxicology & Preclinical Pharmacology
Rate: Negotiable
Job Type: Permanent
Location: Didcot
Director of Toxicology and Preclinical Pharmacology (DMPK)
Location – Didcot, Oxford
Salary: Attractive salary + benefits inclusive of bonus and stock options
A rare position has arose, to work with a clinical stage immunotherapy and vaccine company, developing products to treat and prevent infectious disease and oncology. This is a fantastic opportunity to be part of a well-funded business on a rapid growth trajectory. With a powerful suite of innovative technologies, this a truly exciting time to join the company.
Responsibilities, though not limited to:
- Leadership – provide expert scientific leadership in the areas of toxicology and DMPK to program teams, and ensure preclinical packages support clinical development.
- Toxicology – Lead the development and execution of an integrated and scientifically sound nonclinical safety strategy from lead identification through clinical trial conduct.
- Design, operationalize, and interpret studies to evaluate clinical candidate toxicities, therapeutic index, and overall risk/benefit assessment.
- Key contributor to the selection and timely development of clinical candidate through close interaction with discovery, CMC, clinical and regulatory functions
- Generate concise safety assessments/reports for internal decision making, as well as regulatory submission documentation to facilitate health authority reviews and approval processes in all phases of drug development.
- Provide strategic advice to project teams and senior leaders including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
- DMPK – in partnership with project team, apply understanding of PK/PD and ADME to support product advancement and evaluation.
- Design, operationalize, and analyse DMPK studies to elucidate metabolic fate, drug-drug and transporter interactions.
- Apply state-of-the-art allometric scaling and dose prediction models.
- Assist project team in developing clinical PK and PK/PD plan
- Translational and Biomarker plan – contributes to project transitions from pre-clinical to Clinical Development in close collaboration with discovery and clinical colleagues.
Qualifications:
- PhD, DVM or equivalent and advanced experience in toxicology and/or pharmaceutical sciences
- A minimum of 10 years of experience in the pharmaceutical industry, including significant experience in drug discovery and development, preferably in autoimmunity, infectious diseases, or oncology therapeutic areas, and across several therapeutic modalities.
- GLP knowledge/experience is a plus.
- Board certification such as a DABT is an advantage.
If you are interested in wanting to part of a growth journey and cutting edge science please send your CV to kellie.saul@cpl.com to arrange a conversation