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Clinical Immunology Lead - Vaccines

5+ years
USD 147,000.00 - 212,333.33
10 Oct. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧪 Clinical Immunology Lead – Vaccines

Location: Waltham, Massachusetts / Swiftwater, Pennsylvania
Salary Range: USD 147,000 – 212,333.33
Job Category: Clinical Development / Immunology / Vaccines R&D
Work Type: On-site


🌍 Who We Are

At Sanofi, every day, over 2.5 million vaccine doses reach patients worldwide — driven by innovation, cutting-edge science, and passionate minds. From discovery to delivery, Sanofians are shaping the future of global immunization. With world-class R&D hubs and state-of-the-art manufacturing facilities, we aim to protect communities and stay ahead of infectious diseases through science and collaboration.


🎯 About the Role

Sanofi is seeking a Clinical Immunology Lead to support a diverse and advancing vaccine portfolio.
This role provides strategic and operational leadership for immunogenicity, virologic, and bacteriologic endpoints in late-stage clinical trials.

You will:

  • Drive clinical immunology strategy across vaccine programs.

  • Collaborate with cross-functional teams (R&D, regulatory, clinical, assay development).

  • Ensure scientific rigor, regulatory compliance, and innovation in vaccine development.


🧭 Main Responsibilities

Clinical Strategy & Development

  • Represent Global Immunology on global project teams for late-stage programs.

  • Design, execute, and communicate immunogenicity and clinical trial data.

  • Develop clinical endpoint strategies (serology, mucosal/cell-mediated immunity, efficacy assays).

  • Author and review key regulatory documents (INDs, CTDs, Clinical Protocols, CSRs, e-BLA sections).

Laboratory & Assay Management

  • Guide the development, qualification, and validation of immunologic, virologic, and bacteriologic assays per ICH guidelines.

  • Oversee internal and CRO-based clinical testing activities, scheduling, and troubleshooting.

  • Coordinate biospecimen lifecycle activities, including collection kits, handling, and stability testing.

Data Interpretation & Scientific Communication

  • Review and interpret assay and clinical data to inform study design and regulatory submissions.

  • Act as Subject Matter Expert (SME) in key meetings, scientific conferences, and regulatory discussions.

  • Author high-quality scientific publications and support knowledge dissemination.

Collaboration & Leadership

  • Partner with internal groups like Global Clinical Development, Global Antigen Design, and the mRNA Center of Excellence.

  • Align assay development strategies with Global Clinical Immunology and Strategic Alliances teams.

  • Mentor and motivate scientists, fostering a culture of innovation, inclusion, and excellence.


🧬 About You

Education:

  • Master’s degree in Immunology, Virology, Bacteriology, Molecular Biology, Microbiology, or Cell Biology (required).

  • PhD preferred.

Experience:

  • Minimum 5+ years in immunology, vaccines, antivirals, or monoclonal antibody development.

  • Demonstrated experience in clinical development of vaccines.

Skills & Competencies:

  • Strong understanding of laboratory testing regulations and CRO collaboration.

  • Proven leadership and project management skills.

  • Excellent scientific writing, communication, and presentation abilities.

  • Entrepreneurial mindset with innovation and problem-solving focus.

  • Proficient in data interpretation, process improvement, and scientific strategy.


💡 Why Work With Us

  • Collaborate with a future-focused global team chasing the miracles of science.

  • Enjoy career growth through promotions or international mobility.

  • Receive a comprehensive rewards package, including:

    • Competitive salary & performance bonuses

    • High-quality healthcare and wellness programs

    • At least 14 weeks of gender-neutral parental leave

    • Continuous learning and professional development


🌈 Our Commitment

Sanofi is an Equal Opportunity Employer dedicated to diversity, equity, and inclusion.
We celebrate all backgrounds and ensure fair treatment regardless of race, gender, religion, nationality, or disability.


📢 Join Us

Step into a new era of vaccine innovation and make an impact on millions of lives.
Pursue Progress. Discover Extraordinary — with Sanofi.

#LI-Onsite | #GD-SP | #LI-SP | #VHD

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