Director, Immunogenicity Lead

Site Name : USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Durham

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Posted Date : Aug 23 2024

This is a 3 to 4 day per week onsite role and can be located in Collegeville PA, Waltham MA, or Durham NC.

GSK is currently expanding its Biomarker & Bioanalytical Platforms (BBP) department and is seeking a Director, Immunogenicity Lead to support immunogenicity testing and reporting of biopharmaceutical, oligos and / or cell-based therapeutics candidates.

As an Immunogenicity Lead, this high visibility role works closely with study project teams to determine immunogenicity risk, devise analytical strategies, contribute to protocol design, and provide clinical data interpretation regarding the impact of immunogenicity on PK, safety, and efficacy.

The successful candidate will contribute to regulatory documentation and respond to regulatory questions regarding immunogenicity.

Additional activities include due diligence reviews of potential drug candidates for acquisitions, evaluating the immunogenicity risk.

External immunogenicity method transfer and data generation may also be performed through our CRO partners.

This role requires in-depth knowledge of clinical immunology, immunogenicity analytical method development / validation, and the interpretation and communication of clinical immunogenicity data.

Familiarity with current regulatory guidance and expectations regarding immunogenicity testing and reporting is a must.

Key Responsibilities :

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 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.

Responsible for interpreting immunogenicity clinical data and assessing / communicating the impact (e.g., clinical study report contributions, study team consultations, global safety board).

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.

Contribute to due diligence of prospective acquisitions, including biopharm and C>

drug candidates.

Provide support for review of internal and CRO immunogenicity data. Present scientific and process findings at scientific conferences.

Understand and meet the requirements of all relevant GSK policies, SOPs, and external regulations. Comply with local codes of practice, guidelines, and laws to ensure the strictest requirements are met, particularly regarding promotional versus non-promotional activities.

Basic Qualifications :

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.

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