Associate Director, Safety Scientist

Role Summary

The Associate Director, Safety Sciences provides scientific expertise for medical safety tasks. 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 a 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). Locations: Cambridge, MA; Florida; Gaithersburg, MD; Mid-Atlantic North; Mid-Atlantic South; NY Metro; New England; New Jersey; Southeast.

Responsibilities

• 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 Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s)
• Author periodic reports such as DSURs, PSURs, PBRERs, Risk Management Plans (RMPs), and provide input into structured Benefit Risk Assessments (sBRAs)
• Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
• Contribute or be the primary safety contact person for clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setup
• Mentor new team members by providing training on core safety processes and fostering their development within the organization
• Act as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generation

Qualifications

• At least 5 years of experience in clinical research with significant exposure to pharmacovigilance activities within biotech/pharmaceutical industries or CROs
• Expert knowledge of pharmacovigilance laws/regulations as well as GCP/GVP guidelines
• Proven experience in designing and implementing clinical safety processes/tools and assessing/reporting safety data from clinical trials
• Strong communication skills for organizational/scientific matters with an ability to influence through persuasive appearance
• Proactive mindset with a solution-oriented attitude; adept at handling ambiguity with a balanced approach
• High ethical standards serving as a role model within the organization
• Fluency in written and spoken English

Education

• Advanced degree in life sciences/healthcare; PhD in a relevant discipline or post-doctoral pharmacovigilance certification preferred