Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Durham
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 join as an Immunogenicity Lead to support immunogenicity testing and reporting of biopharmaceutical, oligos and/or cell-based therapeutics candidates.
As an Immunogenicity Lead , the high visibility role works closely with study project teams to determine immunogenicity risk, devise analytical strategies, contribute to protocol design, 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 working 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's of prospective acquisition, including biopharm and drug candidates.
- Provide support for review of internal and CRO immunogenicity data. Present scientific and process findings at scientific conferences.
- To clearly and fully understand and meet the requirements of all relevant GSK policies, SOPs and external regulations. To understand and comply with local codes of practice, guidelines, and laws to ensure the strictest requirements are met, particularly with respect to delivery of 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.