Head of Clinical Safety

Overview

Job Description – Head of Clinical Safety

Position: Head of Clinical Safety

Functional Unit: Drug Safety / Global Clinical Development

Note: Disciplinary and/or technical reporting lines are defined in the current, signed organisational chart and may be subject to change.

Prerequisites and Requirements

• Advanced degree in life sciences, pharmacy, or medicine (MD or veterinary degree preferred).
• Minimum of 10 years’ experience in Clinical Development, including at least 5 years in Clinical Safety.
• Experience in oncology and/or immuno-oncology preferred.
• Significant experience in strategic safety activities, including signal management, risk assessment, safety data review, and interactions with regulatory authorities (US and EU).
• Strong knowledge of regulatory requirements related to GCP and clinical safety.
• Demonstrated managerial skills with experience building and leading a Clinical Safety function.
• Experience with safety databases (commercial safety databases preferred).
• Proficiency in English with excellent written communication skills.
• Full-time availability, with a preference for partial on-site presence during the working week.

Tasks and Responsibilities

• Collaborate cross-functionally with internal stakeholders and external vendors.
• Ensure high-quality safety management within a growing biotechnology organisation.
• Lead and mentor team members and peers on all clinical safety–related topics.
• Manage safety vendors and ensure appropriate sponsor oversight of outsourced activities.
• Author, maintain, and update safety-related SOPs, templates, and forms.
• Ensure inspection readiness and act as internal lead during safety inspections.