Safety Strategy Lead* Vaccines & Infectious Diseases

  • Cambridge, Massachusetts
  • 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.

Safety Strategy Lead* Vaccines & Infectious Diseases

In this role, you are responsible for driving the Safety Strategy of our Vaccines & Infectious Diseases Portfolio, monitoring the benefit-risk profile of assigned products or programs, performing risk management and signal management activities and supporting safety writing activities.
Your main responsibilities are:
  • Lead the Safety Management Team of our Vaccines & Infectious Diseases Portfolio, be responsible for the safety monitoring and risk management of the (development) products assigned to and marketed products originating from the Infectious Diseases platform
  • Responsibility for formulating and driving the optimal development safety strategy for each of the products in clinical development that belong to the Infectious Diseases platform
  • Ensure - in close collaboration with marketing partners - the maintenance of the global RMP of the Comirnaty product and the optimal implementation of any locally approved variation(s), as well as being responsible for the Comirnaty safety signal management
  • Take care that the safety management team maintains a core safety information for each of the products in development that is up-to-date, in accordance with the applicable BioNTech operational procedures
  • Direct the safety management team in formulating and maintaining a development risk management plan for each of the products of the Infectious Diseases platform
  • Be clinical safety subject matter expert for all products (in development and post-marketing) of the Infectious Diseases platform

What you have to offer.

  • Medical degree; in addition, a PhD and/or specialist training in internal medicine, infectiology or public health (vaccines) desirable
  • At least 3 year experience in a leadership position with medical safety responsibility for development and marketed medicinal products, in particular in infectious diseases or vaccines area
  • Expert knowledge of GCP, GVP and global applicable regulatory safety requirements
  • Expert in signal evaluation and risk management
  • Exposure to, or direct experience in working with Regulatory Agencies  
  • Experience in overseeing medical safety staff
  • Have 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
  • Experience in the critical review and editing for consistency of multiple safety-relevant documents concerning one product
  • Strategic thinker; proven team player
  • Excellent English writing skills; 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 4203 (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!

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