Associate Director Safety Sciences

Associate Director Safety Sciences

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 11469

About this Role:

The Associate Director, Safety Sciences provides scientific expertise for medical safety tasks in support of oncology clinical programs. Core responsibilities include safety data review and analysis from different sources, periodic report authoring and the oversight of the safety surveillance activities for the assigned program(s). The Safety Scientist ensures that all processes are conducted according to BioNTech´s written procedures, laws and regulations. The Associate Director Safety Sciences participates in audits and inspections as Subject Matter Expert and works in close collaboration with the Safety Physician to author relevant safety sections of clinical trial documents for the assigned program(s).

Your Contribution:

• Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
• Oversee the Safety Surveillance activities, including signal detection, literature reviews, and aggregate safety data analysis using tools like Safety Dashboards, Spotfire, and Elluminate
• Collaborate with the Safety Physician to author and review safety sections of clinical documents, including Clinical Trial Protocols, Investigator’s Brochures, Informed Consent Forms, and Clinical Study Reports
• Lead the preparation and authoring of periodic safety reports (e.g., DSUR, PBRER) and contribute to regulatory submissions
• Act as a Subject Matter Expert during audits and inspections, ensuring inspection readiness for safety science activities
• Contribute to the development and maintenance of safety-related SOPs and working instructions

BioNTech is an equal opportunities employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic.