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Director, Pharmacokinetics Job
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| Employer Name: BiotechCrossing |
SpiderID: 2221055 |
| Location: Patterson, New York |
Date Posted: 5/12/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Participate in defining department goals and maintaining the budget; Manage/Implement all preclinical, safety, and clinical PK of new chemical entities in various phases of development.More specifically, the Director/Sr. Director will develop and implement clinical pharmacokinetic plans to support development and registration of new drug candidates, with responsibilities for the conduct of pharmacokinetic and ADME aspects of Phase I-IV clinical studies, including study design, data analysis, and writing reports and manuscripts for regulatory submission. Additional responsibilities include representation on drug development teams, preparation of regulatory summary documents, CTD; and effective interaction with and oversight of CRO's.Key Responsibilities and Essential Functions:* Supervise a staff of 4-6 scientists.* Responsible for all aspects of the clinical and non-clinical pharmacokinetic and safety characterization of drug candidates.* Design PK strategies and study protocols for Phase I studies.* Perform and supervise PK and PK/PD analyses.* Prepare documents and reports containing pharmacokinetic or related information for internal use and for regulatory submission.* Work with medical (CMO)to implement PK strategies.* Collaborate with formulation scientists to identify optimal product formulations and configurations.* Oversee development, writing of appropriate clinical and pharmacokinetic SOPs.* Ensure adherence to SOPs, GCP/ICH, and regulatory guidelines.* Interact with outside vendors, CRO's and consultants as needed.* Participate in technical and scientific committee meetings.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.biotechcrossing.com
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