Director Safety Physician

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

The Medical Safety Physician is assigned to one or more study management team(s) in the oncology therapeutic area and together with the assigned Safety Scientist(s) provides Medical Safety Support to the team. Direct responsibilities of the Safety Physician are the input to clinical trial protocol, study site (investigator) training, safety data assessments including adverse events of special interest, assessment of individual serious adverse events, determining the follow up information needed, the safety signal detection and evaluation activities and oversight of compliance with GCP and reporting regulations.

The Safety Physician contributes to the periodic safety reports (DSUR), the relevant updates of reference safety information, the Investigator´s Brochure and Clinical Trial Report.

This is an exciting time to assume a strategic role in MSPv and help translate science into survival by shaping the culture of patient safety for the wider BioNTech organization.

• Medical Degree (or internationally recognized equivalent). A MD/PhD and/or certified training in a relevant medical discipline is a plus.
• Extensive drug safety/pharmacovigilance experience within the biopharmaceutical/biotechnology industry that includes the development of innovative drugs, BLA/MAA submissions, and advisory committee experience, preferably in immuno-oncology/inflammation therapeutic area(s)
• Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, particularly those of US
• Has achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, in particular safety reporting in compliance with global and local regulations

It's our priority to support you:

• Your flexibility: flexible hours |vacation account
• Your value:
  Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle:
  Company bike
• Your life phases:
  Employer-funded pension | Childcare

Apply to our Mainz, Germany;
London, United Kingdom;
Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49
-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job (please always specify if you have any questions)

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 ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!