Clinical Safety Director

21 hours ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time
Job Description for Clinical Safety Director

CK Group is seeking an experienced Clinical Safety Scientist to lead clinical safety activities for a clinical-stage biotech on a contractual basis.

  • Contract Length: 6 months
  • Location: 4 days a week from home, 1 day a week on-site
  • Rate: Circa £100 per hour

Responsibilities:

  • Manage safety within clinical study teams, providing input to the design and preparation of protocols, investigators brochures, informed consent forms, and investigator notification letters.
  • Manage safety evaluation activities, including First in Human (FIH) studies.
  • Conduct regular review of emerging safety data and present important safety issues to senior management, other internal and external stakeholders.
  • Author and/or review aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.
  • Contribute to and summarize safety data effectively for use in regulatory or clinical trial documents.
  • Responsible for coordination and collaboration with external vendors.
Job Requirements
  • 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.
  • Hands-on understanding of the MedDRA.
  • Willingness to challenge and be challenged to ensure optimal decision making and delivery of solutions.


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