BioTalent is pleased to be working with a fast-growing clinical-stage biotechnology company focused on the research and development of immunotherapeutics for various disease areas. They have 9 programmes ongoing and have successfully commercialised one product that has been life-changing globally. You will be joining them as the Director of Toxicology, being the subject matter expert of toxicology and safety pharmacology on all drug discovery and development programmes across the US and UK.
In this role, you will:
- Provide expert scientific leadership in the areas of toxicology and DMPK to project teams, and ensure preclinical packages support clinical development.
- Lead the development and execution of nonclinical safety strategy from lead identification through clinical trial conduct.
- Provide strategic advice to project teams and senior leaders on the potential impacts of toxicology results on program and clinical/regulatory strategy.
- Contribute to the selection and development of clinical candidates through close interaction with discovery, CMC, clinical and regulatory functions.
- Contribute to DMPK strategy through PK/PD and ADME studies to support product progress and evaluation.
- Manage the preparation and presentation of relevant sections of external regulatory documents, e.g. IND, CTA, PIP, etc. and review all regulatory and health authority documents.
- Establish and manage CRO relationships.
You will have:
- PhD or equivalent and 8+ years of toxicology experience within the pharmaceutical or biotechnology industry.
- Experience across a variety of modalities, e.g. biologics, small molecules, nanoparticles, etc.
- Experience leading drug discovery and development programs through milestones, e.g. proof-of-concept and first-in-man studies.
- Experience in immunotherapeutic or vaccines drug development is an advantage.
If you would like to learn more about this exciting opportunity or to recommend a valued professional from your network, you can contact me via or share your CV to email@example.com.
BioTalent Ltd are acting as an employment agency in relation to this opportunity.