Senior Safety Physician, Safety Medical Director (Oncology) - Medical Safety Pharmacovigilance

Open for hire at one of the following locations –  Gaithersburg, Cambridge Erie Street, London, Mainz Goldgrube. - Job ID: 6757 

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 Safety Physician, Safety Medical Director (Oncology) - Medical Safety Pharmacovigilance 

The Safety Medical Director, Oncology - MSPv serves as the physician lead for multiple and/or complex strategically important developmental programs within the oncology and/or infectious disease space.  This role is highly visible in the MSPv and the Global Development Organization and requires working collaboratively as a member of a flexible matrix team to ensure the safety of patients using BioNTech medicinal products. 

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: 

• Represents MSPv as the medical safety expert for BioNTech’s oncology products 

• Serves as a member of the clinical trial core and leader/member of safety teams for assigned products 

• Oversees the benefit-risk profile for assigned products 

• Collaborates on safety monitoring, risk management and signal management activities  

• Presents safety topics at cross-functional teams and internal governance committees 

• Provides medical safety input to periodic safety reports and regulatory health authority (HA) submissions & responses 

• Supports the safety strategy for regulatory submissions of new products, formulations, or indications (NDA/BLA/MAA) 

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

• Provides training and mentorship to other MSPv Scientists and entry level safety physicians 

• Requires 15-20% travel 

Requirements: 

• A Medical Degree (or internationally recognized equivalent) is required. A MD/PhD and/or certified training in a relevant medical discipline is a plus 

• Extensive drug safety/pharmacovigilance experience in the pharmaceutical/biotechnology industry that includes development of innovative drugs, preferably in pulmonary medicine    

• 3+ years of medical safety leadership experience, inclusive of establishing program-level safety strategy for innovative products in development, proactive signal detection & evaluation, risk identification & mitigation planning for early and/or late-stage clinical assets, providing medical input/review into periodic safety reports, Risk Management Plans, health authority responses, SAE assessments, SUSAR reporting and supporting, and supporting NDA/BLA/MAA submissions 

• 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 and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Gaithersburg, Cambridge Erie Street, London, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.

*BioNTech does not tolerate discrimination, favoritism, or harassment based on 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!