Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Clinical Biomarker Lead role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.These responsibilities include some of the following :
Why You? Basic Qualifications:
- 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 (CST). As part of the CMT and CST, establishing clear decision-making criteria to enable biomarker-informed clinical decisions.
- Provide input to clinical teams on biomarker-related elements of clinical protocols, lab manuals and consent forms.
- Develop and implement novel biomarker assays.
- Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
- Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy.
- Point 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.
- Ph.D. or equivalent with minimum of 2 years or MA/MS with minimum 5 years of relevant experience in pharmaceutical industry setting in the application of biomarkers in clinical trials preferably in Oncology
- One or more years experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team
- One or more years experience working in matrixed, multidisciplinary teams
- One more years experience working in a matrixed team environment
If you have the following characteristics, it would be a plus:
- Deep understanding and experience working in the Oncology or Immuno-Oncology Biomarker field
- Experience in high-impact contributions to biomarker discovery and/or assay development
- Experience in Correlative Science or Data Science
- Experience in managing research collaborations, contract laboratories and budgets
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations
- 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
- 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 skills and ability to thrive in a matrix environment
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 is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; and where 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.
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.
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