Clinical research associate Jobs in Bodenheim

Associate Director Clinical Safety Management (m / w / d)

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID : 9007

As Associate Director Clinical Safety Management , you will provide scientific and strategic expertise to our clinical development programs. Core responsibilities include safety data review, periodic report preparation, and global safety database oversight.

Activities and responsibilities

• Provide expert scientific input to clinical safety activities, including safety database analysis, authoring and reviewing study-related documents (e.g., Safety Management Plans, Reconciliation Plans, structured Benefit-Risk Assessments), and leading the preparation of periodic safety reports (e.g., DSURs) in collaboration with cross-functional teams.
• Partner with safety physicians to review and contribute to safety-relevant sections of clinical trial protocols, investigator brochures, clinical study reports, and statistical outputs (tables, figures, listings), and to co-author relevant safety documentation for BioNTech compounds.
• Actively lead or contribute to BioNTech’s Safety Surveillance Teams (SST) and Safety Management Teams (SMT), including meetings to ensure consistent safety oversight, data provision, and decision-making for assigned compounds.
• Drive the development, implementation, and continuous improvement of safety database processes.
• Oversee and enhance strategies and business processes including system configuration, vendor collaboration, and alignment of internal safety processes.
• Serve as primary scientific point of contact for clinical safety team members including best practice approaches, project-specific mentoring and training.
• Support collaboration by providing training and scientific guidance on safety management practices to colleagues in cross-functional departments.
• Build subject matter expertise in focus areas such as data analytics, analytical report outputs, safety database configurations or signal detection.
• Manage and update key standard operating procedures (SOPs) related to safety processes, ensure all safety management activities align with BioNTech’s quality standards, global regulations, and ethical requirements, and act as a Subject Matter Expert during audits and inspections for core safety processes.

What you have to offer :

Your Benefits :