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Scientist Principal in Biotech
∑ 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 primary 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.
Education Bachelorís degree in Science or related scientific field from an accredited college or university; advanced degree preferred.
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