Scientist Principal

Job Advertised by Pharmadiversity Job Board - Under general direction, the clinical scientists plan, coordinate, and execute project-specific clinical research tasks related to the evaluation and development of new therapeutic products.Principal Scientists are expected to operate largely independently and perform at a very high level with significant experience and knowledge in clinical research, therapeutic expertise,with departmental expectations. - Provides significant intellectual contributions to the elaboration of product specific development plans. - Coordinates project work among the clinical research functional group - Develops clinical trial designs and generates protocols. - Provides input for the development of study-specific CRFs and statistical analysis plans. - Participates in the selection of individual study sites and interaction with these sites, including reviewing advertising material, informed consent templates, monitoring reports, and site audits. - Interacts with contract research organizations, local and central institutional review boards, and clinical laboratories on issues that affect the scientific integrity of the study. - Provides primary leadership on bioanalytical method development and validation activities, as well as non-clinical research. - Assists in the processing of serious adverse events. - Reviews completed CRFs, medical coding, determines protocol violations, and provides scientific input to assure subject safety and the quality and integrity of study data. - Interprets study outcomes and produces final clinical study reports, investigator brochures, annual reports, regulatory responses, and marketing application submissions. - Develops, prepares, and presents scientific programs and presentations for internal and outside audiences. - Participates in quality efforts of the department. - Will have p rimary responsibility for the selection and oversight of vendors/consultants providing bioanalytical services, pre-clinical services, non-clinical services, scientific consulting, and survey instruments. - Assists in the due diligence process in which new in-license compounds are evaluated. - Performs other duties as assigned .Fourteen (14) years related pharmaceutical laboratory experience, or an equivalent combination of education and experience. Knowledge of: * Regulations concerning the conduct of bioanalytical, preclinical, and clinical research * Current clinical research procedures and practices *Principles and practices of therapeutics and pharmacokinetics * Statistical principles and their application to clinical research *usiness and scientific personal computer hardware and softwareBachelor's degree in Science or related scientific field from an accredited college or university; advanced degree preferred.. br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=559468&tag=aje