Clinical Biomarker Lead

The Clinical Biomarker Lead, 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 biomarker lead will establish clear decision-making criteria to enable informed clinical decisions and integrate the biomarker strategy into the clinical development plans. The Clinical Biomarker Lead 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 the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Developing and maintaining project clinical biomarker strategy including approaches to pharmacodynamic and predictive biomarkers.

• Representing biomarker strategy at the EDT/MDT, study teams and Protocol Review Forum.

• Providing input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, Study Reference Manuals and Central Lab Worksheets.

• Establishing and delivering budget plans for biomarkers to EDT/MDT

• Working with Research Unit project biologist to ensure alignment of preclinical and clinical biomarker strategies.

• Working with internal technology groups, Contract Research Organizations and collaborators to deliver clinically validated biomarker assays into clinical studies.

• Developing companion diagnostic strategies for validation, implementation and regulatory approval of predictive biomarkers.

• Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements.

• As part of the EDT/MDT establishing clear decision-making criteria to enable informed clinical decisions.

• Point contact for resolving study biomarker issues.

• As required, contributing to the study design, biomarker implementation and analysis of observational studies, Investigator Sponsored Studies and collaborative/consortia approaches.

• As required, supporting the expansion of mechanism and disease understanding of approved drugs to generate insights that can be leveraged in indication expansion and marketing.

 Why you?

Basic Qualifications:

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

• Scientist and/or Physician (PhD, MD or equivalent)

• 1 years of experience in the application of biomarkers in clinical trials.

Preferred Qualifications:

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

• Expertise in the development of clinical biomarkers for neurodegenerative diseases.

• Expertise in either a specific research area and/or biomarker technology

• Experience in conducting clinical trials and working as part of a clinical study team in industry.

• Knowledge and track-record of working to GCP principles.

• Expertise in the discovery, validation and clinical implementation of biomarkers.

• Strong understanding and experience of predictive biomarkers, including diagnostic development.

• Knowledge and experience of biomarker technologies and their clinical implementation.

• Strong interpersonal skills and ability to thrive in a matrix environment.Ability to influence teams and key stakeholders with a proven track record of success.

• Preference will be given to candidates with experience and knowledge of neurodegeneration.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.

• Managing individual and team performance.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

• Implementing change initiatives and leading change.

• Sustaining energy and well-being, building resilience in teams

• Continuously looking for opportunities to learn, build skills and share learning both internally and externally

• Developing people and building a talent pipeline

• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation

• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally

• Budgeting and forecasting, commercial and financial acumen.

#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.

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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Salary : $106,000 - $134,000