Medical Evidence Generation Lead E Coli Sepsis - Vaccine

About the E coli Sepsis Vaccine Franchise

• Sanofi Vaccines is the Global Business Unit (GBU) of Sanofi responsible for Vaccines and prophylactic treatments for infectious diseases.

• Sanofi has engaged in a collaborative agreement with Johnson & Johnson Innovative Medicines to develop and commercialize the vaccine candidate for extraintestinal pathogenic E. coli (9-valent).  

• Extraintestinal pathogenic E. coli (ExPEC) has been identified as the leading bacterial cause of sepsis, causing approximately 10 million cases of invasive ExPEC disease annually, worldwide. It is associated with increased hospitalizations, mortality and antimicrobial resistance resulting in significant healthcare and societal costs.

• The agreement with our partner, Johnson & Johnson, includes worldwide co-development, co-commercialization, and license for the current 9-valent vaccine candidate as well as lifecycle management candidates. Johnson & Johnson will manage R&D and Sanofi will manage commercialization and medical activities.

About the job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Our Team:

The successful candidate will be joining a highly motivated, collaborative and innovative medical team of dedicated to delivering the highest quality of evidence through innovative science to finalize the development and to prepare the entry in the market of this new vaccine candidate.

The incumbent will report to the Global Medical Franchise Head, who has delegated coordination of daily activities to the ExPEC Franchise Medical Evidence Generation Lead responsible for the research program.

In this role, you will (1) Contribute to the development of an efficient and innovative research program to support this new asset, (2) Lead the development and timely execution of select studies identified in the research program, (3) Contribute to the strategic and targeted use and dissemination of medical evidence, (4) Participate in external scientific engagement, (5) Provide internal stakeholders with strategic scientific advice & medical evidence.

Main Responsibilities:

Under the supervision of the Global Medical Franchise Head, the Global Medical Evidence Generation Lead will:

• Contribute to an efficient and innovative research program to support the development and to prepare the entry in the market of a new vaccine candidate

• Participate in a cross-functional evidence generation team to identify and prioritize key gaps in evidence required to support development and business strategies, including co-creation with representatives from priority countries

• Maximize the value of medical evidence by ensuring that the Franchise research agenda combines scientific excellence with novel evidence generation approaches as well as external insights

• Lead the development and timely execution of select studies identified in the research program

• Ensure study methodology meets the highest quality standards for internal and external recognition. This entails both internal reviews and external stakeholder and expert engagement

• Leverage internal expertise and external partnerships to foster agile and efficient study implementation, and ensure appropriate governance, compliance, resourcing (internal and external) for study conduct

• Be accountable for the efficient and timely execution of select studies, including mitigation of potential issues and roadblocks

• Lead and guide the interpretation and critical evaluation of study results, and participate in study results reporting and dissemination

• Where needed, serve as the primary point of contact with external investigators and study teams

• Contribute to the strategic and targeted use and dissemination of medical evidence

• Take an active part in the development and execution of the Franchise scientific communication plan with a focus on ensuring optimal and adequate evidence use for select studies, including active participation as a lead or co-author on publications and abstracts

• Organize the dissemination of newly generated evidence among a network of external experts to optimize research impact

• Support and participate in commu