About SNBL USA
Join us in our mission to help free patients from suffering and improve patient care and treatment outcomes. Headquartered in Everett, WA, SNBL USA, Ltd. offers a unique range of safety assessment services to fulfill its commitment to help free patients from suffering. Managed and operated by a team world renowned for its wide-ranging drug development experience and expertise, SNBL USA offers programs ranging from regulatory toxicology to customized study designs. SNBL's specialized capabilities include safety assessment of biologics, reproductive toxicology, cardiovascular, respiratory and CNS pharmacology, immunotoxicology and carcinogenicity.
SNBL USA, Ltd. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status.
The Study Director represents the single point of control for preclinical studies and is responsible for the interpretation, analysis, documentation, and reporting of study results.
• Overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. Assures that Sponsors are appropriately informed throughout the length of the study.
• Performs functions in accordance with GLPs and other applicable regulations and/or guidances.
• Consults with Sponsor, Study Directors and others during protocol development to optimize protocol design to appropriately address study objectives
• Responds to inquiries from clients and other relevant parties regarding scientific aspects of studies. Actively participates in client discussions regarding studies.
• Coordinates the schedule and logistics of the study with clients, sub-contractors, and relevant internal departments.
• Assures that current copies of approved protocol and amendments are available to all study personnel and Sponsors.
• Prepares the Project Review Form and obtains approval of the study by the IACUC.
• Monitors, tracks, and communicates study milestones throughout departments.
• Assures that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
• Analyzes and interprets study data and prepares study reports; may be assigned to serve as a Contributing Scientist or a Principal Investigator.
• Responds to internal and external Quality Assurance (QA) audits to maintain compliance.
• Confirms that all raw data, documentation, protocol, specimens, and study reports are transferred to the archives during or at the close of the study.
• Stays informed of current industry practices through research and review of scientific literature and regulatory documents.
• Reviews, revises, and writes SOPs, as necessary.
• Masters or Doctoral Degree or equivalent degree in a relevant scientific discipline. A Baccalaureate or equivalent degree and relevant experience may substitute for the education requirements.
• Minimum 2-5 years of GLP study director experience required, preferably in a CRO environment.
• Verbal and written communication skills in English; the ability to read, analyze, understand, discuss and interpret complex scientific and regulatory documents. Ability to effectively communicate scientific data interpretation and conclusions
• Demonstrated expertise in a scientific discipline.
• Strong planning and organizational skills, with the ability to manage change.
• Ability to work effectively and cooperatively in a team environment under significant time pressure.
• Demonstrated attention to detail and consistent ability to operate with accuracy and quality.
• Proven presentation and facilitation skills.
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