Research Scientist I, Drug Safety Evaluation
Location: Foster City
Description: Gilead is currently interviewing Research Scientist I, Drug Safety Evaluation right now, this vacancy will be placed in California. Further informations about this vacancy opportunity please read the description below. Monitors and coordinates all aspects of outsourced non-GLP and GLP nonclinical safety pharmacology and toxicology studies in support of research and development programs
ï¶ Reviews protocols, data and study reports for accuracy and consistency
ï¶ Provides QC review of study protocols, reports, and regulatory submission documents including nonclinical sections of Investigator Brochures and Common Technical Documents (CTD)
ï¶ Serves as DSE representative on Research teams and may serve as nonclinical sub-te! am member on Development Team(s)
ï¶ Travel is required
Essential Duties and Job Functions:
ï¶ Independently monitors and coordinates all aspects of outsourced non-GLP and GLP nonclinical safety pharmacology and toxicology studies.
ï¶ Reviews protocols, data and study reports ensuring presentation of data in report is accurate and supports the conclusions drawn
ï¶ Provides QC review of study protocols and reports as well as regulatory submission documents
ï¶ Actively participates in protocol development and dose selection
ï¶ Prepares exhibits and tables to convey study results
ï¶ Presents study designs and results within DSE and may present to stakeholders outside of DSE
ï¶ Prepares tabulated summaries and other tables for nonclinical regulatory documents
ï¶ May prepare written summaries and other nonclinical regulatory documents
ï¶ May review regulatory submission documents for scientific content
ï¶ Serve as DSE Representative on Research teams
ï¶ May serve as! nonclinical sub-team member on Development Team(s)
ï¶ May lead departmental initiatives and/or participate on cross-function initiative teams
ï¶ Able to do scientific literature searches
Knowledge, Experience and Skills:
ï¶ PhD in pharmacology/toxicology or related scientific discipline, or a BS or MS degree in related scientific discipline with 5+ (MS) or 7+ (BS) years of industry experience in small molecule and/or biopharmaceutical drug development
ï¶ Excellent verbal and written communication skills, interpersonal skills, teamwork and decision-making skills are required
ï¶ Knowledge and understanding of GLPs
ï¶ Basic knowledge of nonclinical requirements to support research projects
ï¶ Awareness or knowledge of regulatory requirements, including ICH and other regional requirements that impact drug development.
ï¶ Strong organization skills and attention to detail, along with the ability to prioritize multiple task! s and plan proactively to achieve goals with tight timelines
ï¶ Ab! le to work independently as needed
ï¶ Must have strong computer skills such as Word, PowerPoint, and Excel
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Gilead.
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This vacancy starts available on: Mon, 02 Dec 2013 18:55:59 GMT