Director* Clinical Safety Management

  • Mainz
  • Work experience
  • Medicine, Pharmacy, Laboratory
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Director* Clinical Safety Management

As Director* Clinical Safety Management, you will design, implement and improve Clinical Safety Management processes to support the development of BioNTech’s development products. You are responsible for leading and developing the Clinical Safety Management team, as well as supporting and working closely together with the Safety Governance, Clinical Development, Clinical Development Safety and Clinical Operations teams.
Your main responsibilities are:
  • Leading and developing the Clinical Safety Management Team
  • Ensuring that effective Clinical Safety Management activities are established and are compliant with GCP, global regulations and quality standards for BioNTech’s clinical development programs
  • Supporting the Safety Governance, Clinical Development, the Clinical Development Safety and Clinical Operations teams to ensure successful clinical development programs, representing the Clinical Safety Management team in discussions with development partners and during audits and inspections
  • Overseeing external Clinical Safety Management resources and CROs performing Clinical Safety Management activities for BioNTech
  • Providing input into the safety sections of clinical documents, including DSURs, IBs, study protocols and reports, responses to regulatory authorities, dRMPs and submission packages

What you have to offer.

  • University Degree (Master's or equivalent) in a Medical area, Biology, Public Health or Pharmacy
  • At least 5 years of experience in clinical safety and clinical operations within the pharmaceutical industry, biotech or CRO
  • Expert knowledge of GCP and global Pharmacovigilance regulations and processes
  • Experience in establishing, designing, implementing and managing clinical safety processes, documents, systems and tools
  • Experience in managing teams responsible for clinical safety operations, clinical operations and/or pharmacovigilance
  • Expert knowledge of global safety clinical safety reporting regulations, including US, EU, and UK requirements
  • Very good English skills (written and spoken); German is a plus

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 
(monday-friday, from 12 noon to 4 pm).

Job-ID 5200 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de