Clinical Biomarker Director
UK, Stevenage
UK, GSK HQ
US, Waltham, MA
US, Upper Providence, PA
On-site presence of 2-3 days per week average is anticipated. Additional flexible arrangements considered on case-by-case basis.
Job Purpose:
The Clinical Biomarker Lead (Director), Precision Medicine will lead the development and effective implementation of biomarker and precision medicine strategies in support of clinical development of assets. The Clinical Biomarker Leader will establish clear decision-making criteria to enable data driven clinical decisions, identify patient segmentation strategies and integrate the strategy into the clinical development plans.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
* Leading the conceptualization, alignment and delivery of Clinical Biomarker Strategies on behalf of Precision Medicine
* Representing Precision Medicine at Early Development/Medicine Development Teams (EDT/MDT) and/or Clinical Matrix Teams (CMT) establishing clear biomarker driven decision-making criteria to enable clinical development
* Identify cutting edge science and technological advances and incorporate them into biomarker strategies to guide indication selection, patient enrichment, and combination strategies
* Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives.
* Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.
* Manage effective working relationships with translational science, clinical operations, medical affairs, regulatory, portfolio management and commercial functions
* Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs
* Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations)
* Establish and deliver budget plans for biomarkers to MDT
* Working with Research Unit biology leads, Translational Science leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker and CDx strategies.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* PhD/MD in Respiratory or a related discipline required
* Experience in strategic leadership roles within Clinical Biomarkers and Translational Research
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Expertise in leading the development of clinical biomarker strategies with a proven track record of success
* Extensive experience in Respiratory translational research, with proven track record of high-impact contributions to biomarker discovery and implementation of biomarker strategy into clinical development
* Demonstrable leadership of matrix team structures across functional disciplines
* Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams
* Ability to influence teams and key stakeholders with a proven track record of success
* Experience with authoring clinical and regulatory documents
* Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
* Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
* Deep knowledge of Respiratory biology, biomarker strategies and application to clinical trials
* Knowledge and track-record of working to GCP principles
* Strong interpersonal skills and ability to thrive in a matrix environment.
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