Director, Group Leader Biomarker CPEM, Open to flexible working
Are you looking for a leadership role that allows you to shape and define an innovative clinical biomarker strategy as part of a new and growing team? Are you passionate about accelerating the delivery of transformational medicines in the Immunology space? Does targeting therapies to the patients who benefit most, appeal to you?
As a Clinical Biomarker Group Lead, you will lead a team of Clinical Biomarker Leads and have responsibility for development and effective implementation of biomarker strategies in support of clinical development projects.
Working as part of the early development / medicine development matrix teams (EDT/MDT), you 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.
Click on the link to hear more about this role from Robbie Henderson, Head Clinical Biomarkers.
This role will provide YOU the opportunity to drive key activities and responsibilities as follows:
- Lead a team of Clinical Biomarker Leads who support drug discovery and development programmes across the GSK pipeline. Setting aligned, stretched objectives, driving performance, creating an environment to maximize the outcomes for the team and GSK R&D.
- Manage resource allocation across projects and work with Clinical Biomarker Head to ensure optimal resource allocation across the portfolio
- Review team biomarker strategies and provide direction and guidance
- Enable team deliverables by ensuring the availability of state-of-the art platform technologies and resource is optimal to support biomarker portfolio
- Work with Head of Clinical Biomarkers to ensure that biomarker strategy aligns with overall Clinical Pharmacology Experimental Medicine strategy
- Perform Biomarker Lead role for key projects - which will include 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
- 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 required, supporting the expansion of mechanism and disease understanding to generate insights that can be leveraged in indication expansion and marketing
*** Please note: For this position, we have flexibility on the level of appointment across Director grades, based on the level and type of experience ***
We are looking for professionals with these required skills to achieve our goals:
- PhD-educated scientist (or equivalent) with at demonstrated experience in the application of biomarkers in clinical trials
- Recognised team leader with proven people-management skills
- Expertise in the development of clinical biomarkers with a proven track record of success
- 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
In addition to the minimum qualifications, the ideal candidate will possess the following:
- 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
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