Vaccines
Where
extraordinary minds
help protect  half a billion people

About the job

Sanofi is recruiting a Global Clinical Immunology leader to support a diverse and growing portfolio of vaccines targeting infectious diseases.  This role has provided strategic guidance and operational support for immunogenicity, virologic, and bacterial endpoints in late-stage clinical trials.  As a part of the global project team, the successful applicant will contribute to the development of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the strategy for and assays supporting serology, mucosal/ cell mediated immunogenicity, efficacy-supporting diagnostics, and next generation sequencing endpoints for a late-stage program.  The successful applicant will operate at an extremely fast pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development experts.

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.

Main responsibilities:

• Represent Global Immunology (GI) on the global project team to design, execute, and communicate data from clinical trials from multiple late stage programs

• Scientifically review and provide interpretation of both assay development and clinical development data and experimental designs

• Write / review regulatory documents

• Support and coordinate all clinical testing activities (internal or at 3rd party laboratories) related to Project including communication of resource needs, assisting Lab Coordinators with scheduling for routine testing and with the Scientists/Lead technicians for test development or troubleshooting by providing the necessary scientific expertise

• Lead and influence evaluation and improvement of new/existing technologies; ensure the development and qualification/validation of robust immunologic, virologic, and bacteriologic assays that meet ICH guidelines to support clinical studies

• Serve as function representative and SME at key strategic internal/external meetings, conferences/congresses, and key meetings with CROs and with regulatory authorities.

• Act as a contributing author to high-quality publications describing assay development and/or the immunogenicity and efficacy of candidate and approved drugs in technical, medical, or scientific journals

About you

• Experience: 10 years post-MS or 4 years post-PhD experience, preferably with experience contributing to translational or interventional clinical studies

• Skills:

• Entrepreneurial mindset with positive energy and strong sense of determination

• Proven leadership, verbal and written communication, organizational and team management skills

• Proven ability to develop and implement new procedures/processes. Familiarity with laboratory testing regulations both internally and externally (CROs) is a plus.

• Project management and computer skills required

• Record of innovation as evidenced by a strong publication record, inventorship on patents/filings and presentations at major conferences

• Education: MS, or PhD in Virology, Bacteriology, Immunology, Molecular Biology, Microbiology, Cell Biology, or other relevant scientific fields

Languages: English Fluent