An exciting opportunity on the Management Team of a leading Biotech has become available as the Head of Non-Clinical Studies. The position requires experience in designing, planning, conducting, monitoring, interpretation of results and reporting of non-clinical safety studies in collaboration with project teams. The ideal candidate shall have in depth experience leading toxicology studies and significant product development experience in a GLP environment.
Head of Non-Clinical Studies Key Responsibilities:
- Develop the non-clinical strategy for company portfolio of early stage products and advise for their partnered programs
- Design, conduct and report of non-clinical safety studies
- Identify, assess and audit CRO facilities for studies to be conducted
- Act as Study Director, Study Monitor and Principle Investigator for non-clinical safety studies delivering on budget and on time
- Prepare regulatory documentation (CTAs, IMPDs, INDs, NDAs etc) and interact with authorities as needed
- Communicate toxicology data to project teams and ensures delivery in line with product development plans
- Provide budgeting and forecasting information to the overall project budget
- Identify risks to the pre-clinical safety plan, proposing options for resolution/mitigation
- Maintain toxicology expertise, keeping up to date with scientific literature, attending and contributing to scientific meetings
- Education, PhD in Toxicology, Pharmacology or Biomedical Sciences
- Experience, 7+ years post PhD experience in a pharmaceutical or biotechnology company or CRO managing toxicology studies
- Ability to interact successfully in a cross functional team setting
- Experience working with common toxicology species
- Significant product development experience in running non-clinical safety studies
- Familiarity with GLP regulations and regulatory guidelines for testing,
- Excellent communication skills with strong strategic vision
This is a fantastic opportunity as a Head of Non-Clinical Studies is available on a permanent basis, offering the right individual a fantastic platform to further their career with a targeted portfolio of potential market leading therapeutics.
Please call Charles on 01619427163 for more details on package and applying.