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Immunogenicity Lead Director

2 months ago

Waltham, Massachusetts, United States GlaxoSmithKline Full time

About the Role:

We are seeking a highly skilled and experienced Immunogenicity Lead Director to join our team at GlaxoSmithKline. As a key member of our Biomarker & Bioanalytical Platforms department, you will play a critical role in supporting immunogenicity testing and reporting of biopharmaceutical, oligos and/or cell-based therapeutics candidates.

Key Responsibilities:

  • Develop and Implement Immunogenicity Strategies: Set immunogenicity analytical clinical strategy based on drug candidate's immunogenicity risk assessment, including appropriate assay formats, to support the study teams prior to initiation of clinical development, with updates as required.
  • Provide Expert Recommendations: Provide expert recommendations regarding immunogenicity assessments in clinical study design by working with the study team, and reporting layouts (e.g., sampling, assays, tables, figures, and listings) by collaborating with the statistics & programming teams.
  • Interpret Immunogenicity Data: Responsible for interpreting immunogenicity clinical data and assessing/communicating the impact (e.g., clinical study report contributions, study team consultations, global safety board).
  • Regulatory Documentation: Produce and contribute to regulatory documentation (e.g., m2.5, m2.7.1, m2.7.2, m2.7.4, integrated summary of immunogenicity) and respond to regulatory questions in a timely manner.
  • Due Diligence and Data Review: Contribute to due diligence of prospective acquisitions, including biopharm and C> drug candidates, and provide support for review of internal and CRO immunogenicity data.
  • Scientific Presentations: Present scientific and process findings at scientific conferences.
  • Compliance and Governance: Understand and meet the requirements of all relevant GSK policies, SOPs, and external regulations, and comply with local codes of practice, guidelines, and laws to ensure the strictest requirements are met, particularly regarding promotional versus non-promotional activities.

Requirements:

  • PhD in Immunology or related field or BS or MS and > 8 years in clinical immunogenicity.
  • 8 years or more in pharmaceutical or biotechnology research supporting clinical testing of immunogenicity.
  • Experience working in the pharmaceutical or biotechnology industry with in-depth understanding of the drug development process.
  • Experience in developing and validating methods used to support immunogenicity testing for biologic or cell-based therapeutics.
  • Experience preparing analyses and reporting clinical biopharmaceutical immunogenicity data and its context to the study or project.

Preferred Qualifications:

  • PhD or equivalent in Immunology or related field.
  • Demonstrated experience contributing immunogenicity support to BLA/MAA filings.
  • Demonstrated experience supporting biotherapeutic project teams in oncology, pulmonary, immunology, or infectious disease areas.
  • Management of timelines and operational aspects of data delivery supporting drug development.
  • Demonstrated effective communication and negotiation skills for a wide variety of audiences, including laboratory analysts and senior management.
  • Courage to lead and make tough decisions and evidence of strong influencing capability.
  • Keen interest in collaborating with external experts.
  • Ability to prioritize and manage multiple projects simultaneously.
  • Demonstrated ability to manage complexity and cultural diversity.
  • Strong interpersonal, verbal, and written communication skills.