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Clinical Biomarker Lead, Virologist

3 months ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence, Home Worker - GBR, Home Worker - USA, UK - Hertfordshire - Stevenage
Posted Date: Aug

Join us today to translate great science into therapies as a Clinical Biomarker Lead Virologist. In this role, you will have responsibility for development and effective implementation of biomarker strategy in support of project clinical development. Working as part of the early development / medicine development matrix teams (EDT/MDT), the Clinical Virology Biomarker Lead will establish clear decision-making criteria to enable informed clinical decisions and integrate the strategy into the clinical development plans. You will employ cutting edge technologies and procedures to discover and clinically validate biomarkers. The implementation of the biomarker strategy as part of a well thought through clinical plan will ensure optimally informed decision making in drug development.

This role will provide YOU with the opportunity to progress YOUR career, these responsibilities include:
  • Develop and deliver virology biomarker strategy including approaches to pharmacodynamic biomarkers, disease related biomarkers, clinically validated biomarkers and/or companion diagnostics for clinical phase programs including HBV, SARS-CoV2, influenza and/or HRV to enable informed clinical decisions
  • Detection and monitoring or viral resistance during treatment and in the global community
  • Represent virology biomarker strategy on EDT/MDT, study teams and at internal governance reviews as well as serve as point of contact for study virology biomarker issues
  • Providing input to clinical teams on virology issues that may affect clinical studies, e.g. selection and transmission of variants and the effect on the efficacy of the molecule, incidence of viral disease in the community
  • Ensure alignment of virology biomarker outputs with clinical team to meet study requirements
  • Lead writing of virology reports to support study teams and regulatory submissions as well as contribute to virology and biomarker sections of publications


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Scientist and/or Physician (PhD, MD) and 3+ years post-graduate or industry experience
  • Experience in Virology and clinical drug development
  • Experience in molecular biology including technologies, techniques and data analysis


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience and knowledge of viral resistance
  • Experience in deep sequencing and/or computational biology
  • Expertise in the discovery, validation and clinical implementation of biomarkers with a proven track record of success
  • Experience in conducting clinical trials and working as part of a clinical study team including working to GCP principles
  • Experience with diagnostic development
  • Ability to analyze and interpret molecular data sets
  • Ability to solve problems
  • Strong writing and presentation skills
  • Strong interpersonal skills and ability to thrive in a team setting
  • Ability to influence teams and key leaders with a proven track record of success


#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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