Location: Leiden, The Netherlands
Closing Date: 30 Nov 16
Salary (£): On Application
You will work closely with drug development project teams to ensure successful execution of protocols. You will play a key role in the design, conduct, analysis, and reporting of phase I-III clinical trials including protocol development, evaluation of safety information, data analysis and interpretation, and report writing.
You may participate in one or more study teams and may have oversight of multiple study protocols. Your presence at the Dutch office for a minimum of 3 days a week is required.
DUTIES & RESPONSIBILITIES
The Clinical Research Physician
• Provides medical/scientific input to clinical protocols and to study objectives, to selection of study populations, variables and selection of appropriate testing to monitor the safety of subjects during the study
• Is primarily responsible for medical and safety monitoring by detailed review of single patient data of enrolled subjects in Phase I-III studies.
• Participates in interpretation and assessment of trial data and supports the writing of clinical study reports.
• Supports medical sciences in regulatory interactions and negotiations.
• Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, and regulatory). This includes review of published scientific medical literature relevant for the execution of the clinical study protocols.
• Develops or maintains knowledge of therapeutic area specialty to ensure protocol is appropriately designed and executed from a medical/scientific perspective.
• Registered and licensed MD or equivalent.
• 1-3 years hospital experience as treating Physician
• At least 2-3 years of experience in drug development at a biotech or pharmaceutical company as Study Physician or Medical Monitor in Clinical R&D Good working knowledge of regulatory procedures and Good Clinical Practice guidelines.
• Able to work effectively across different functions and cultures
• Experience in Urology and / or Nephrology is preferred.
Schipholweg 111, 2316 XC Leiden, Netherlands
|Tel:||+31 71 711 2500|
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