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The following opportunity exists in our South San Francisco, CA facility:Clinical Scientist Specialist
Job ID: 1000033302
South San Francisco, CARESPONSIBILITIES: The Clinical Science Specialist assists the Clinical Scientist in overall study planning, management, evaluation, and documentation. Assists or leads full protocol development and participates in study management as a clinical science representative. Provides clinical scientific input for final study reports and annual report documentation. Assists in high-level IND and NDA documentation process.
The current position is predominantly for Support on the OCEANS trial, but also with responsibilities on GOG218. The CSS will serve as primary CS liaison for the team and primary point of contact for medical monitor inquiries from CRO/Site monitors, triaging questions regarding protocol inquires, waiver/deviation requests, modifications to informed consent safety/risk information and reviewing of monitoring reports/corrective action plans. In conjunction with Medical Director, the CSS will create and/or review clinical slides for internal and external meetings (i.e. Investigators' telconferences, PSSV/SIVs, Study Coordinator/CRA training). The CSS will also perform clinical review of data listings. The CSS may also review and create materials (including slide decks) to Support post Marketing and commercial activities. This may include commercial advisory boards (i.e. community advisory boards, regional advisory boards, etc.), as well as working with medical communications triage external calls and ensure appropriate materials/letter are available for external distribution.
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Principal functional responsibilities:
 Provide input into the Strategic planning of a project.
 Provide input and review of SDV plans based on protocol specifications.
 Establish glossaries, review and provide input for database conventions, edit checks, data displays, and case report form summaries.
 Attend and provide science Support for investigator and consultant meetings and monitors workshops.
 Participate in the ongoing review of study data.
 Participate in SAE report process according to SOP's.
 Participate in the review of narratives and provide feedback as needed.
 Participate in the writing of final study reports.
 Participate in NDA documentation and preparation of materials for use in presentation.
 Assist in providing response to regulatory agency questions and preparation of advisory committee meetings.
 Coordinate, prepare, and review study results for publications, abstracts, poster presentations and scientific meetings.
Qualifications and experience:
* Good clinical research experience, preferably in oncology with an overall knowledge of drug development process.
* A team player with ability to interact with individuals and groups in other functional areas as well as outside the company.
* Effective written and verbal communication skills.
* Experience in reviewing trial protocol violations, serious adverse event reports and tumor assessment data.
* Experience in writing and reviewing narratives and provide feedback as needed.
* Ability to process information, analyze data, and reach conclusions based on sound reasoning.
Educational background:
B.S. or equivalent scientific qualification - minimum requirement.
Advanced Clinical/Science degree, M.S., PharmD or PhD preferred.
Research experience in Oncology is an advantage.
DIVISION: Late Stage Clinical Devt
REQUISITION NUMBER: 10-1000033302 Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # 1000033302 . Please use ?Web ? BAJobs? when a source is requested. Genentech is an Equal Opportunity Employer. | | |
