Safety Strategy Lead* Oncology

Become a member of the BioNTech Family!

As part of our team of more than 4,000 pioneers, you'll play a central role in solving some of the greatest scientific challenges of our time. In less than a year, we were able to develop our COVID-19 mRNA vaccine to the highest scientific and ethical standards – by far the fastest vaccine development in the history of medicine.
 
Our goal is 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. In doing so, we are guided by our three corporate values: innovation, passion and cohesion. If you also want to contribute to giving hope for a healthy future to many people, then we should get to know each other!

 

 

Safety Strategy Lead Oncology MSPv


Your main responsibilities are:

  • Oversight of, and accountability for the quality performance of one or more safety management team(s) that each are responsible for the safety monitoring, signal management and benefit risk assessment of a program; 
  • At portfolio level, the responsibility to formulate and drive the optimal development safety strategy for the respective oncology programs in clinical development;
  • Where applicable, presentations on safety matters at regulatory authority meetings;
  • Responsibility for a regular assessment of the Benefit Risk assessment of the products in development; may decide that an emergent safety issue/product alert deserves escalation up to the executive safety governance body for arbitration and/or action;
  • Leadership to ensure that single case reporting, signal management and risk management activities which occur under his/ her direction and competence, are performed at all times in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards; 
  • Oversight on the quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator’s brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries and other clinical/regulatory documents as needed;
  • Participation in due diligence for BioNTech’s Licensing /Acquisition initiatives; assure the representation of medical safety in Alliance management projects such as safety data exchange agreement negotiations; representation of medical safety in joint oversight committees with development partners, or participation in other collaborative development projects;
  • The Safety Strategy Lead is the safety subject matter expert at the portfolio level and is the arbiter for safety related issues in any of its constituting programs, as they may arise.

 

What you have to offer.

 

  • Several years of experience in the innovative pharmaceutical industry, of which 3 years of medical safety leadership experience in the development of advanced therapeutic medicinal products and/or cellular therapy and/or immuno-oncology products
  • Medical Degree. In addition, a PhD and/or a clinical specialism certification in internal medicine, clinical oncology, hemato-oncology, etc., preferred 
  • Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, in particular those of US and EU
  • Experience in overseeing medical safety staff
  • Have achieved demonstrable results with a multidisciplinary team in a matrix organization
  • Holds him/herself accountable for achieving high ethical standards in work and behaviours
  • Above-average communication skills: able to express complex analyses in concise, clear language; finds persuasive arguments; and, an excellent command of the English language.

 

Benefits for you. 

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits supporting our diverse employee base. We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

Please click the link below to review a highlight of our benefits -
https://www.biontech.com/int/en/home/careers/working-at-biontech.html

 

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Cambridge Erie Street, Gaithersburg, Mainz Goldgrube. Apply now for your preferred locations and simply send us your application documents using our online form.

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality,
ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health
status or any other aspect of personal status. We are committed to creating a diverse and inclusive
environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you
www.biontech.com