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.
We seek experience within one of these areas: Neurosciences, NASH, Immunology.Primary Responsibilities and Accountabilities:
- 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
Why you? Basic Qualifications:
- 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 Organisations 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
We are looking for professionals with these required skills to achieve our goals:
- Scientist and/or Physician (PhD, MD or equivalent) with at least 1-3 years of experience in the application of biomarkers in clinical trials.
- Experience within the Neurosciences, NASH, or Immunology.
If you have the following characteristics, it would be a plus:
- Expertise in the development of clinical biomarkers
- 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
- 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
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:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
- 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.
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