Reference: PW 6668
Closing Date: 22 Jan 17
Salary (£): Competitive
Benefits: Car allowance, bonus, Life assurance, pension, health, dental, PHI etc.
Top Global Pharma with an attractive portfolio and pipeline
Innovative, ethical and supportive working environment
Excellent transport links and onsite parking
Contribute to the organisation by analyzing and communicating results for studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring for these and, possibly, other studies
CDP Development and Management
Directs and implements clinical research plans and programs according to established design principles
Directs the integration of the CDP and the DDP
Clinical Research Protocols
Leads the development of Clinical Protocols to meet CDP objectives
Serves as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data
Clinical/ Medical and Safety Monitoring
Serves as Medical Monitor and possibly Study Director for a study or clinical program, reviews and monitors study safety data
Implements strategies to identify, monitor and resolve clinical program/ trial issues
Clinical Research Expert
Serves as SME to provide direction to all project team functions, organises Advisory Board meetings (e.g., agenda setting), and identifies and liaises with KOLs regarding program strategy and scientific advice
Additionally, this individual will contribute to the organization by analysing and communicating results for these studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring for these and, possibly, other studies.
QUALIFICATIONS / EXPERIENCE REQUIRED:
This position requires a dynamic individual with an MD and/or PhD degree and significant experience in the pharmaceutical industry working on Phase II / III studies
• Demonstrated experience in pharmaceutical clinical development, with experience in directing Neurology Phase 2-3 global multicentre studies
• A thorough understanding of clinical research methodology including study design, protocol writing, and study report preparation
• Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action
• Knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience
• Knowledge of medical, scientific and clinical research techniques in the neurology area
• Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology
For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference PW 6668.
Only candidates with EU work authorisation will be considered.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
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