US-PA-Assistant Director Clinical Pharmacokineticist

To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/
Date: 15-Jul-2008

Assistant Director Clinical Pharmacokineticist

Job Summary

Responsible for devising and directing pharmacokinetic (PK)/ pharmacodynamic (PD) aspects of Early Development and Clinical Pharmacology strategies and plans for all IND-track and development compounds. Manages all aspects including scientific development and design, implementation, analysis, interpretation and reporting of PK/PD results in early and late stage clinical programs. Represents Early Development and Clinical Pharmacology at strategy, development and therapy area level teams and including regulatory meetings. Responsible for preparing and compiling clinical pharmacology aspects of global regulatory submission and documents.

Job Responsibilities

*Lead preparation and execution of Early Development and Clinical Pharmacology plans and strategy to meet corporate, scientific and regulatory needs.

*Design and implement data analysis plans for characterization of PK/PD data from clinical studies at all development stages for an assigned project, and provide prediction/simulation of PK/PD events to support the project at various decision points, using standard and more advanced PK/PD approaches.

*Represent Early Development and Clinical Pharmacology on interdisciplinary project teams, including Learn/Confirm teams, clinical teams and subteams thereof as appropriate.

*Ensure that Early Development and Clinical Pharmacology initiatives and messages are well supported through publication strategies and through manuscript publications and presentations at global meetings; champion Early Development and Clinical Pharmacology initiatives at clinical investigator meetings, advisory meetings and various scientific forums.

*Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated pharmacokinetic and pharmacodynamic modeling and simulation initiatives, including population pharmacokinetic and pharmacokinetic/pharmacodynamic analyses.

*Provide mentoring and leadership to Early Development and Clinical Pharmacology staff and study team members.

Basic Qualifications

*The incumbent must possess a Ph.D. in pharmacokinetics or a related discipline with 4 years of experience in pharmacokinetics within the pharmaceutical industry. In-depth understanding of all aspects of PK/PD applications, especially in the area of pharmacometric application to drug development, is required.

*The incumbent should have on the job experience or training with a range of skills including pharmacokinetic analysis, population approaches in constructing PK/PD models, performing simulations and making predictions and have experience with pharmacokinetic SOFTWARE, statistical analysis SOFTWARE and modeling and simulation SOFTWARE such as NONMEM, SPLUS and/or SAS. In addition, the incumbent should have experience in preparing clinical pharmacology sections of various regulatory documents.

*The incumbent should also have experience within a team environment, have strong presentation skills, collaborative skills, negotiation skills and demonstrate self-motivation. Training is principally on the job in the pharmaceutical industry.

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/