Date: 19-Apr-2011
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please visit http://biotech.fyicenter.com/
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
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/