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Medical Evidence Generation Lead E Coli Sepsis - Vaccine

AT Sanofi U.S.
Sanofi U.S.

Medical Evidence Generation Lead E Coli Sepsis - Vaccine

Gunnison, CO

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 pathogenicE.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.

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  • 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 agendacombines 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 communication of scientific and medical evidence (e.g. congresses, masterclasses, internal & external trainings)
    • Participate in external scientific engagements including with academic/professional societies, regulatory agencies and recommending bodies to support Franchise business and public affairs strategy with scientific & medical evidence
    • Provide internal stakeholders with strategic scientific advice & medical evidence in coordination with Medical Product Lead to support and inform market access, policy strategies and product positioning

    About you
    • Education: PhD in Epidemiology/Public Health or MD plus related MSc/MPH in Epidemiology
    • Experience: You have 5+ years of experience in the field of clinical/epidemiology/public health research with expertise in developing epidemiological studies, , as well as study management and publications.
    • Soft skills: this job requires effective communication, negotiation, and interpersonal skills. These skills are required specifically to address the following typical challenges encountered in the position
    • Effectively communicating evidence-based advice with the perspective of influencing strategy decisions,
    • Managing with discernment and acumen the interactions with external partners to maintain productive collaborations in evidence generation and in advisory activities, with a focus on company strategic ambitions,
    • Technical skills: this job has a core scientific mission, which requires
      • Extensive scientific expertise in medical/public health and vaccine research, including study design, set-up and execution, evidenced by a strong publication record in peer-reviewed literature
      • Demonstrated ability to critically assess data, methods and study designs, and relate those aspects to evolving product strategy
      • An innovative mindset in terms of study design and evolution of the field is important
    • Languages: Fluent in English

    Why Choose Us?
    • Bring the miracles of science to life alongside a supportive, future-focused team.
    • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
    • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
    • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

    Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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    Client-provided location(s): United States
    Job ID: Sanofi-https://jobs.sanofi.com/en/job/bridgewater/medical-evidence-generation-lead-e-coli-sepsis-vaccine/2649/16023469696
    Employment Type: Other