Are you interested in the development of novel, integrated biomarker work to support projects across clinical development for Oncology? Are you searching for a position where you will be working as a key contributor to clinical matrix team (CMT), medicines development team (MDT) and leading development and integration of biomarker strategy into clinical development plans? If so, the Associate Director, Clinical Biomarker role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• Lead and/or contribute to clinical asset biomarker strategy within early and late stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
• Represent EMU Biomarker team at Clinical Matrix Teams (CMT) and clinical trial study teams (ST). As part of the CMT and clinical ST, establishing clear decision-making criteria to enable biomarker-informed clinical decisions.
• Develop and implement novel biomarker assays with robust assay validation.
• Provide input to clinical teams on biomarker-related elements of clinical protocols, lab manuals, regulatory documents, and consent forms.
• Provide scientific expertise and technical guidance to enable timely biomarker sample collection and analysis including from high dimensional assays.
• Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy.
• Point of contact for resolving study biomarker issues.
• Collaborate with clinical operations and sample management to ensure biomarker testing and data generation
• Align with the companion diagnostics team to deliver novel precision medicine approaches to select patients for treatment.
• Serve as a point of contact for external vendors and collaborators in support of data generation
• Provide frequent project status updates related to biomarker deliverables

Basic Qualifications:

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

• Ph.D. or equivalent with 4 years or more years of, integrated biomarker work within clinical development or
• MA/MS degree with 5 or more years of integrated biomarker work within clinical development
• Experience in the pharmaceutical industry
• Experience in the application of biomarkers in clinical trials
• Experience in high-impact contributions to biomarker discovery and/or assay development
• Experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team

Preferred Qualifications:

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

• Experience in managing research collaborations, contract laboratories and budgets
• Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
• Therapeutic work experience in Oncology
• Correlative Science Experience
• Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation
• Flexibility to work on multiple projects as the portfolio evolves over time.
• Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
• Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials.
• Experience with clinical flow cytometry, immunohistochemistry and/or immunoassay development
• Knowledge and track-record of working to GCP principles
• Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
• Strong interpersonal and communication skills as well as ability to thrive in a matrix environment

#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 positively impact the health of 2.5 billion people by the end of 2030.

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