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US-Seattle-Washington: Senior Scientist in Biotech

Date: 19-Apr-2011
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Senior Scientist in Biotech

Responsibilities: „h Plan, design, analyze, interpret and report pharmacokinetic and pharmacodynamic data from pre.clinical and clinical studies „h Prepare PK, PK/PD and population PK sections of study protocols, study reports, project summaries and development plans „h Prepare PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB and other regulatory documents) „h Interact cross.functionally across departments including Research, Clinical Operations, Clinical Development, Biostatistics and Regulatory Affair groups „h Interpret and present project related study results and recommendations to management and relevant project teams „h Act as representative for preclinical and clinical PK function on project teams Requirements:

„h Ph.D. in pharmacology, pharmacokinetics, or related discipline. „h Experience in planning, designing, interpreting and reporting of preclinical and clinical pharmacokinetic and pharmacodynamic studies „h Proficiency with WinNonLin software and other commonly used PK and PK/PD software. „h Excellent written and oral communication skills and interpersonal skills. Preferred: „h Ph.D. or equivalent with minimum 3 years experience in pharmaceutical or biotechnology industries „h Experience with development of ophthalmic drugs. Extensive PK and PK/PD study design, implementation and analyses experience. „h Experience in performing PK, PD and PK/PD modeling and simulations

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BioTech FYI Center
http://biotech.fyicenter.com/