Location(s): USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage

Clinical Pharmacology & Experimental Medicine (CPEM) serves as a translational bridge between GSK research units and late clinical development. We leverage expertise in human disease, clinical pharmacology, biomarkers, imaging, and experimental medicine to define the optimal destination for cutting edge science to impact patient lives. It is under this umbrella that Clinical Biomarkers resides.

At GSK, science is at the heart of everything we do. Join us to translate that great science into therapies as a Clinical Biomarker Lead (Associate Director).

In this role, you will have responsibility for development and effective implementation of biomarker and precision medicine strategy in support of clinical development of assets. Working as part of the early development / medicine development matrix teams (EDT/MDT), the Clinical Biomarker Lead will establish clear decision-making criteria to enable informed clinical decisions, identify patient segmentation strategies and integrate the strategy into the clinical development plans. You will employ cutting edge technologies and analysis methods 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 and identification of the right patient population for our medicines.

This role will provide YOU with the opportunity to progress YOUR career, and your responsibilities include:

• Develop and deliver immunology and disease biomarker strategies including approaches to pharmacodynamic biomarkers, proof-of-mechanism and patient stratification biomarkers, for clinical phase programs in SARs-COV2, influenza, HBV and/or HRV to enable informed clinical decisions.
• Develop and deliver precision medicine strategy to identify predictive biomarkers to enable clinical success.
• Represent biomarker strategy at EDT/MDT, study teams and at internal governance reviews as well as serve as biomarker point of contact for clinical studies.
• Ensure alignment of biomarker outputs with clinical team to meet study requirements.
• Lead writing of reports to support study teams and regulatory submissions as well as contribute to publications.
• Support the expansion of mechanism and disease understanding to generate insights that can be leveraged for indication expansion and scientific exchange.
• Work closely with analysis teams to develop integrated analysis approaches to use high dimensional data to understand disease, patient subpopulations, mechanisms of drug response, and inform combination strategies.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• PhD/MD with strong background in immunology and at least 3 years post-graduate or industry experience
• Master’s degree and 5+ years’ experience with strong background in immunology
• Experience in molecular biology including technologies, techniques and data analysis (e.g. flow cytometry, transcriptomics, proteomics, immuno-based assays).
• Experience analyzing and interpreting molecular data sets.
• Expertise in the discovery, validation and clinical implementation of biomarkers with a proven track record of success.

Preferred Qualifications:

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

• Experience and knowledge of infectious disease
• Experience in deep sequencing and/or computational biology.
• 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 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.

Why GSK?

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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