Job Description

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 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 to/for to 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

A Good Match:

• Advanced degree in life sciences/healthcare; PhD in a relevant discipline or post-doctoral pharmacovigilance certification preferred
• At least 5 years of experience in clinical research with significant exposure to pharmacovigilance activities within biotech/pharmaceutical industries or CROs
• Therapeutic area experience in oncology is required; experience in oncology clinical trials and/or oncology pharmacovigilance strongly preferred
• 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

Your benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.