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Director, Immunogenicity Lead

2 months ago

Durham, North Carolina, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled and experienced Clinical Immunology Expert to join our team as an Immunogenicity Lead. This is a key role that will play a critical part in the development of our biopharmaceutical products.

Key Responsibilities
  • Immunogenicity Risk Assessment: Develop and implement strategies to assess and mitigate immunogenicity risk in our biopharmaceutical products.
  • Method Development and Validation: Design, develop, and validate analytical methods used to support immunogenicity testing.
  • Data Interpretation and Reporting: Interpret and communicate clinical immunogenicity data to support regulatory submissions and business decisions.
  • Regulatory Compliance: Ensure compliance with current regulatory guidance and expectations regarding immunogenicity testing and reporting.
  • Collaboration and Communication: Work closely with cross-functional teams, including study project teams, statistics and programming teams, and regulatory affairs teams, to ensure seamless communication and collaboration.
Requirements
  • PhD in Immunology or related field or equivalent experience in clinical immunology.
  • 8+ years of experience in pharmaceutical or biotechnology research supporting clinical testing of immunogenicity.
  • Experience in developing and validating methods used to support immunogenicity testing for biologic or cell-based therapeutics.
  • Strong analytical and problem-solving skills with the ability to interpret complex data and communicate results effectively.
  • Excellent communication and collaboration skills with the ability to work effectively in a team environment.
What We Offer

As a Clinical Immunology Expert at GlaxoSmithKline, you will have the opportunity to work on cutting-edge projects, collaborate with a talented team of scientists and professionals, and contribute to the development of innovative biopharmaceutical products. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.