Head of Non-Clinical Studies

Job title: Head of Non-Clinical Studies
Contract Type: Permanent
Location: Cambridge
Salary: Strong package.
Reference: BH-96339-1
Contact Name: Charles Leach
Phone Number: 44 161 942 4000
Job Published: 26 days ago

Job Description

Head of Non-Clinical Studies – Cambridge – Permanent

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
Head of Non-Clinical Studies Key Requirements:
  • Education, PhD in Toxicology, Pharmacology or Biomedical Sciences
  • Experience, 8 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 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.