Our client, a world leading Pharmaceutical organisation, are currently looking for a Preclinical Toxicology Scientist to join their Drug Development Group based from their state-of-the-art facilities in Surrey, UK.
This is an outstanding opportunity to join an early phase drug development group that manages a broad portfolio of new molecular entities from candidate selection through clinical Proof of Concept (PoC).
Working as a Preclinical Toxicology Scientist, you will be responsible for all phases of the toxicology and ADME plans for a product portfolio ranging from large biologics (antibodies, proteins and peptides) to small molecules.
Your duties will include creation and implementation of preclinical toxicology/ADME plans; development of safety assessment plans; approval of methodology, protocols and final study reports; project management activities related to preclinical work product (timeline, scope, budget, risk mitigation, contingency plans) as well as working closely with quality and regulatory to prepare nonclinical ADME safety pharmacology and toxicology sections of IB, INDs, CTD, IMPDs and other regulatory documentation.
As part of the role, you will also be required to build, establish and communicate a network of preclinical toxicology/ADME content experts as well as a network of external contract vendors to support activities.
To be considered for this role, you will meet the following criteria:
- Degree / MSc / PhD in Toxicology
- Veterinarian Medicine
- Occupational Health
- Health Sciences or a related discipline (or equivalent)
- Ability to identify structural/chemical class problems that will guide preclinical activities around specific identified issues with a compound.
- Extensive experience working in Toxicology/ADME or equivalent.
- Proven practical experience working across multiple phases of drug development.
- Demonstrated experience preparing GLP regulatory documentation: ICH, FDA, and EMEA non clinical safety, toxicology and ADME guidance.
For more information, or to apply for this Preclinical Toxiciology Scientist position, please contact Jason Johal at CK Science on 01438 723 500 or email email@example.com. Please quote reference ST20902 in all correspondence.
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