Our client is aclinical stage biotech company leading the development of new therapies for rare diseases. The company’s leading program is currently in an ongoing phase 2/3 clinical trial for the treatment Central Nervous System disease.
Support or lead development and implementation of translational medicine strategies for CNS drug candidates, including evaluation of pharmacodynamics in preclinal and clinical studies.
Partner with clinical and research groups to execute high quality biomarker strategies.
Evaluate, interpret, and present clinical biomarker data to guide project decisions and direction.
Drive efforts to evaluate and implement novel, state of the art technologies and concepts for clinical and non-clinical biomarker studies.
Implement standardized and cutting-edge tools in clinical trials to establish target engagement and develop patient selection biomarker strategies.
Design and perform experiments to elucidate mechanisms of action and progression of the diseases that can be developed into biomarkers and new therapeutics.
Contribute to and review of investigators brochures, protocols and reviews.
Revise and analyse scientific projects
Establish and maintain liaison with key opinion leaders, academic groups and CROs to ensure that significant developments in the field are identified and monitored
Monitor journal publications and conference presentations for relevant developments
PhD with 4+ years of related work experiencein the Pharmaceutical Industry or Biotech/Start-up companies
Strong scientific background in biology (neurosciences) and orphan indications and good knowledge of –omics applications supported by publication record in these areas
Clinical development experience interacting with teams conducting clinical trials
Demonstrated leadership in translational sciences, employing pharmacodynamic, predictive and exploratory biomarkers
Experience in analysis of large datasets and knowledge of biostatistics
Experience in assay development, qualification and implementing biomarker assays on diverse platforms including IHC/IF, gene expression profiling, flow cytometry
Collaboration, documentation and presentation skills
Skill in Microsoft Office Tools (Excel, Word, PowerPoint)
Excellency in written and spoken English as second language
Flexibility, autonomous, good time management, team-working skills, stress resistant
Prepared to travel to clinical investigational sites, conferences and meeting.
Ability to work proactively and delivering results under tight timelines
Well-developed communication skills, problem solving skills, creative thinking
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