Senior Director, Safety Strategy Lead (Oncology) - Medical Safety Pharmacovigilance

Open for hire at one of the following locations –  Mainz Goldgrube, Cambridge Erie Street. - Job ID: 6754 

 

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.

 

Senior Director, Safety Strategy Lead (Oncology) - Medical Safety Pharmacovigilance 

 

The Safety Strategy Lead Oncology MSPv serves as the Senior Medical Safety Physician for multiple and/or complex strategically important developmental programs and works collaboratively as a member of a flexible matrix team to ensure the safety of patients using BioNTech medicinal products. The role will lead the safety of multiple oncology and/or infectious disease assets which span across all phases of development, and include delivery through one or more in-house, outsourced, and alliance delivery models. This role is highly visible in the MSPv and 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.  

 

Responsibilities: 

 

• Accountable for the quality performance of one or more safety management team(s) (SMTs) 

• Oversees safety monitoring, signal management, and the benefit-risk of assigned products through the product life cycle 

• Identifies and leads escalation, management, and communication of safety inquiries and concerns for assigned products 

• Formulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level 

• Presents and interacts with Regulatory Authorities on safety matters 

• Oversees 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 

• Participates in due diligence for BioNTech’s Licensing /Acquisition initiatives 

• Represents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projects 

• Serves as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programs 

• Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards 

• Trains and mentors Safety Physicians and Safety Scientists 

• Requires 15-20% travel 

 

Responsibilities:

 

• 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) 

• 3+ years of medical safety leadership experience desired 

• 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 

 

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications