|
Director Modeling and Simulation
From:
Company: Daiichi Sankyo (see all of this employer's jobs)
Edison Edison
, 08817
United States
Contact: Recruiter
Apply by eMail:15333784.185@jobfrenzy1.com
Apply by eMail:15333784.185@jobfrenzy1.com
|
Job Reference ID:
DF15333784
Category:
General Management
Duration:
Full Time
City, ST:
Edison, New Jersey
Country:
United States |
|
Description:
Job Summary:
Ensure state-of-the-art modeling and simulation is used during preclinical and clinical development to support product development and decision making.
Responsibilities:
Develop and implement modeling and simulation plans for compounds in development that contribute to dose selection, sample size power, sampling scheme, issue resolution and decision making in conjunction with Translational Medicine, Clinical Pharmacology and Clinical Development.
Conduct key model based analyses and interact with external partners to conduct these analyses.
Develop innovative study designs for translational medicine and clinical pharmacology studies.
Work with Bioinformatics on strategies to support translational medicine and clinical pharmacology activities.
Support model based predictions of human pharmacokinetics and pharmacodynamics based on preclinical data.
Education/Experience Requirements:
Ph.D. in Pharmaceutical sciences or equivalent.
Minimum requirement 8 years clinical pharmacology and pharmacokinetics experience, including implementation of state of art modeling and simulation to support compound development. Expertise in M&S in support of cardiovascular, oncology and diabetics preferred.
In-depth knowledge of current regulatory requirements (FDA, GCP and ICH).
Ability to work independently and to effectively prioritize, proactively identify and resolve problems and work in a team environment.
Must possess excellent communication and interpersonal skills, as well as effective collaboration and negotiation techniques.
Highly proficient in standard computer software (Word, Excel and Power Point) and helpful to have proficiency in specialized software for pharmacokinetic data analysis.
Demonstrated experience in population pharmacokinetic-pharmacodynamic modeling required using NONMEM. Experience in clinical trials simulation desirable.
Must be willing to travel atleast 20% of the time.
Requirements:
See Above
Education: Not Specified
Experience: Not Specified
Travel: None
Apply by eMail:15333784.185@jobfrenzy1.com
Apply by eMail:15333784.185@jobfrenzy1.com
Job Created:
Sat Oct 17 2009 04:27:17 AM
Last Modified: Sat Oct 17 2009 04:27:17 AM
|
