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Ellen Capito-Wightman, President
Corp. Phone (860) 535-4419
FAX (860) 535-1842
FULL-TIME POSITIONS
Clinical Pharmacology Scientist
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Clinical Pharmacology Scientist
Clinical Pharmacology Scientist, Experimental Medicine
Posted February 26, 2007
Early Drug Development
3 to 5 Years Experience
Summitt, N.J.
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JOB DESCRIPTION:
 Assists Experimental Medicine Director/Associate Director in generating, maintaining, and executing an Early Drug Development Plan for selected drug candidate through close collaboration with other EDD and CRD departments.
 Contributes to the planning, managing, implementing, monitoring and reporting of FTIH single and multiple dose trials to characterize the safety, tolerance, pharmacokinetics and pharmacodynemics (when appropriate biomarkers are available) in healthy volunteers and/or patients.
 Contributes to the planning, managing, implementing, monitoring and reporting of EDD trials designed to characterize the pharmacodynamics, and proof of biological activities, using appropriate endpoints or biomarkers. Provides experimental medicine supports to other departments and line functions Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings.
 Track progress of all assigned programs and associated trials and deliverables Assists the Director/Associate Director in formulating budgets for assigned studies and works with Operations Department and Director in selecting CRO's, obtains contracts and authorizes grant payments to be processed against grants.
 Tracks grant payments against contracts and annual Experimental Medicine Budget. Conducts site visits, as necessary Participates in multidisciplinary task forces in support of continuous improvement & other pro ject objectives.
JOB REQUIREMENTS:
 Knowledge and Skills: Advanced degree (Ph.D./Pharm. D./DVM or equivalent) in life sciences with at least 2 years of relevant clinical research experience, preferable in human pharmacology is required.
 Knowledge of the drug development process, early drug development clinical trial design and practices, pharmacodynamics and clinical pharmacokinetics, and FDA and ICH regulations regarding conduct of clinical studies (GCP) is highly desired.
 The candidate should have good oral communication and interpersonal skills as well as the ability to write scientific documents. Knowledge of data processing methods and statistical analyses is preferred.
 The incumbent must be computer literate.
 The candidate is required to have good project and time management skills so that tight deadlines can be met with only minimal guidance from the Director/Associate Director, Experimental Medicine.
 The candidate should have the ability to differentiate critical events at study sites and to communicate effectively these issues to the appropriate parties.
 Excellent organization, managerial, and interpersonal skills are important.
 Ability and willingness to work within a matrix environment and ability to function as representative on project teams are required
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The Artac Seel Company
--Effectively Delivering Talent in Pharmaceuticals & Biotech--
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