Biomarker Lead - UK 12 months Freelance role
- Contract Type
Our Client are looking to bring on a Biomarker Lead for a 12-month freelance role based from the M4 corridor office with 2 days a week home based if required.
- This role is accountable for devising the biomarker strategy for assigned projects across their development lifecycle
- This will include identifying and proposing innovative and feasible biomarkers aligned to the clinical development strategy to support decision making, enable stratified medicine/diagnostic approaches and overall enhance the probability of successful development and approval of the asset.
- Biomarker Lead will be considered a Subject Matter Expert in biomarker technologies, their development and implementation.
- The role will therefore require deep understanding and appreciation of the scientific, technical, regulatory, intellectual property and preferably commercial considerations for successful biomarker implementation to drug development programmes.
- Masters or PHD in a relevant research or life science discipline
- Strong understanding of the implementation and use biomarkers in an industrial drug development environment.
- Good knowledge of early clinical development with proven track record of successful contribution to projects.
- Proven track record of contacts with academic experts in experimental medicine techniques related to the research areas of interest
- Knowledge of overall drug development process.
- Credible, in-depth knowledge and experience of the implementation of biomarkers in drug development with understanding of the clinical application of such markers, their evaluation and analysis and ideally linkage between the biomarker as surrogate marker and the clinical endpoints.
- Ability to present a well-reasoned business case and influence other departmental leaders to support cross functional implementation of new initiatives and projects.
- Ability to communicate effectively with internal and external opinion leaders including pharmaceutical regulatory agencies, e.g. FDA, EMEA.
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