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Director Immunogenicity Subject Matter Expert

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Jul 8, 2022

View more

Discipline
Life Sciences, Immunology
Job Type
President/CEO/Director/VP
Organization Type
All Industry, Pharma
We are currently looking to expand our Bioanalysis, Immunogenicity and Biomarkers (BIB) department and are seeking a Director to join bringing strong experience supporting immunogenicity testing and reporting of biopharm and/or cell-based therapeutics.

The role is based at Upper Providence, PA in the US with opportunities for flexible and/or remote working available. The role reports directly into the Senior Director, Head of Immunogenicity.

As the successful candidate, you will join GSK in a high visibility role working closely with drug project teams to determine immunogenicity risk, devise analytical strategy, contribute to study design, provide clinical data interpretation regarding the impact of immunogenicity on safety and efficacy. The successful candidate will contribute to regulatory documentation and respond to regulatory questions regarding immunogenicity. Additionally, the incumbent will contribute to due diligence reviews of potential biopharm and cell/gene therapy acquisitions. When capacity allows, 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 methods 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 include, but are not limited to:
  • Set Immunogenicity analytical strategy (risk assessment at CS, right assays applied according to immunogenicity risk) for teams at candidate selection and update as required
  • Provide expert recommendations regarding study and reporting design input (e.g. sampling, assays, tables, figures and listings) for immunogenicity testing components
  • Responsible for immunogenicity clinical data interpretation and assessing/communicating impact ( e.g. clinical study report contributions, team consultations, Immunology Safety Panel)
  • Produce and defend regulatory documentation (e.g. integrated summary of immunogenicity, responses to regulatory questions)
  • Contribute due diligence support for biopharm and C> compounds/prospective acquisitions
  • Provide support of external data generation, when capacity allows


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD or equivalent in Biomedical Sciences
  • 5 years in pharmaceutical or biotechnology research and/or development supporting clinical testing of immunogenicity
  • Experience working in the pharmaceutical or biotechnology industry with in-depth understanding of the drug development process
  • Expertise in developing and validating methods used to support immunogenicity testing for biologic of cell-based therapeutics
  • Experience preparing analyses and reporting preclinical and/or clinical biopharmaceutical immunogenicity data and its context to the study or project


Preferred Qualifications:

If you have the following characteristics, it would be a plus:

(Immunology or Pharmacology preferred)
  • PhD or equivalent in Immunology or Pharmacology with immunogenicity support experience
  • 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.
  • Excellent spoken and written English skills


Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​

​With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​

​Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.​

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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