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Clinical Safety Expert

1 month ago

Cambridge, Cambridgeshire, United Kingdom CK Group Full time £100
Clinical Safety Expert - Associate Director

This role involves leading clinical safety activities for a clinical-stage biotech company. Responsibilities include managing safety within clinical study teams, providing input to protocol design, and reviewing emerging safety data. The ideal candidate will have significant experience in clinical safety and excellent knowledge of regulations such as FDA, EU, and ICH.

Key Responsibilities:
  • Manage safety evaluation activities, including First in Human (FIH) studies.
  • Carry out regular review of emerging safety data and present important safety issues to senior management and stakeholders.
  • Author and/or review aggregate safety assessments and drug safety reports.
  • Contribute to and summarize safety data for use in regulatory documents.

Your Background:
  • Significant experience in clinical safety.
  • Excellent knowledge of all phases from first in man to post approval.
  • Solid working knowledge of relevant regulations.
  • Previous experience of managing clinical safety activities for multiple programmes.