Director* Medical Safety

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, Mainz K1. - Job ID: 4272 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 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* Medical Safety 

 

We are committed to improving people’s health worldwide with our fundamental research and development of immunotherapies. We believe in scientific rigor, innovation, and passion as driving forces. Scientists and physicians founded BioNTech to translate science into survival by combining fundamental research and operational excellence.

 

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria, and tuberculosis. The first-ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany.

 

BioNTech continues to expand its mRNA platform and its global immunotherapy powerhouse, and we are inviting experienced safety professionals to help us grow our internal patient safety expertise! We are seeking director-level Safety Scientists with experience successfully leading global clinical programs and MAA/BLA submissions.

 

The Director of Medical Safety (Scientist) will lead the medical strategy and clinical risk management planning of multiple complex products within the Oncology Therapeutic Portfolios (Infectious Diseases Portfolio). Reporting to the Head of Medical Safety, you will work collaboratively with the Safety Strategy Lead (SSL), Safety Physician (SP), Safety Managers (SM), and other Scientists and Physicians with leadership in project teams and across matrix organization, including counterparts within Core Teams, Clinical Program Teams, Global Regulatory Affairs, and other cross-functional delivery groups.

The role may span multiple oncology assets and the entire life cycle of drug development and peri-/post-submission, from the early to late phases of development, and include delivery through one or more in-house, outsourced, and alliance delivery models. This role is highly visible in MSPV and in the Global Development Organization (GDO).

 

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. BioNTech’s pipeline, which includes mRNA, CAR-T, cancer vaccines, and other breakthrough technologies across different drug classes poised to revolutionize medicine, provides an intellectual challenge to the safety teams requiring a broad portfolio and scientific management approach to projects.

Key qualities include demonstrated ability to provide safety scientific input and leadership for programs/safety management teams through strategic and operational safety expertise and excellence in stakeholder management. This role requires competent strategic thinking, solution-finding, agility, adaptability, comfort with grey areas, impeccable communication skills, tact, and the ability to lead and drive change.

Required behaviors include effectiveness at building networks of partners and stakeholders, continuous learning and curiosity, and the ability to provide clarity, teach, lead, and inspire others. A track record of effective peer communication and shared learning is critical.

 

Key Responsibilities:

 

• Lead one or more Safety Management Team(s) and support the conduct of internal/independent data monitoring review boards.
• Lead the safety surveillance strategy and the presentation of sophisticated safety topics at cross-functional teams and internal governance committees.
• Provide strategic input and author periodic safety reports and regulatory health authority (HA) submissions & responses.
• Partner with the SSL and other MSPV members to lead the safety strategy for regulatory submissions of new products, formulations, or indications (NDA/BLA, MAA).
• Participate in due diligence activities, negotiating the PV agreements and safety componen