Clinical Immunology Lead - Vaccines

Job Title: Clinical Immunology Lead - Vaccines

Location: Waltham, MA or Swiftwater, PA

About the Job

Sanofi is recruiting for a Clinical Immunology Lead to support a diverse and maturing portfolio of vaccines targeting infectious diseases. This role provides 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 clinical endpoints and develop 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

• Write/review regulatory documents such as INDs, CTDs, Clinical Trial Protocols, CSRs, and e-BLA sections

• Ensure the development and qualification/validation of robust immunologic, virologic, and bacteriologic assays that meet ICH guidelines to support clinical studies

• Support and coordinate all clinical testing activities (internal or at third 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

• Liaise with biosamples leadership to determine key components of sample lifecycle (biospecimens being collected, biospecimen collection kit composition, biospecimen handling and stability, etc.), and to generate the analysis testing plan

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

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

• Lead and influence evaluation and improvement of new/existing technologies

• 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

Management of Key Interfaces

• Work closely within Sanofi Vaccines (both R&D and Medical), including One Operations (1 Ops), Global Clinical Development (GCD), leaders in Global Antigen Design (GAD), mRNA Center of Excellence and various medical franchise teams to ensure that clinical testing strategy is designed to maximize scientific quality and timeliness whilst operating within budget targets

• Collaborate with Head of Strategic Alliances and Head of Global Clinical immunology to ensure strategy for assay development, validation, and testing is performed according to plan and within expected timelines

People and Organization

• Provide scientific guidance and line of sight to product development to inspire and motivate internal and external stakeholders to continuously strive for excellence

• Model Inclusion and Diversity principles and behaviors in all ways of working

• Strengthen the team and the company by creating a winning spirit and by developing excellence-oriented and customer-focused culture, while fostering innovation

About You

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