Clinical Immunology Lead - Vaccines

Role Summary

Clinical Immunology Lead - Vaccines is a strategic role within Sanofi focused on guiding immunogenicity, virologic, and bacteriologic endpoints in late-stage vaccine trials. The role contributes to clinical protocol development, provides scientific and regulatory support, and defines endpoints and strategies for serology, mucosal/cell-mediated immunogenicity, efficacy-supporting diagnostics, and next generation sequencing endpoints. The position requires collaboration with global project teams, physicians, regulatory leaders, CMC, discovery scientists, and assay development experts. Location: Waltham, MA or Swiftwater, PA.

Responsibilities

• Represent Global Immunology on the global project team to design, execute, and communicate data from clinical trials across multiple late-stage programs
• Write/review regulatory documents such as INDs, CTDs, Clinical Trial Protocols, CSRs, and e-BLA sections
• Ensure 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 the project, including communication of resource needs and assisting Lab Coordinators with scheduling for routine testing and with scientists/lead technicians for test development or troubleshooting
• 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 vaccines
• Work closely within Sanofi Vaccines with R&D and Medical, One Operations, Global Clinical Development, Global Antigen Design, 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
• 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

Qualifications

• Required: Masters degree in Virology, Bacteriology, Immunology, Molecular Biology, Microbiology, Cell Biology, or other relevant scientific field
• Preferred: PhD in the above-mentioned fields
• Required: 5+ years of experience in immunology, vaccines, antiviral or monoclonal antibody development with some experience supporting the clinical development of vaccines

Skills

• Familiarity with laboratory testing regulations both internally and externally (CROs)
• Entrepreneurial mindset with positive energy and strong sense of determination
• Record of innovation as evidenced by a strong publication record, inventorship on patents/filings and presentations at major conferences
• Proven leadership, verbal and written communication, organizational and team management skills
• Proven ability to develop and implement new procedures/processes
• Project management and computer skills required