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Clinical Research Scientist, Sr. at Immune Design
South San Francisco, CA, US
Overview

The Sr. Clinical Research Scientist oversees and develops clinical projects including component studies, providing strategic input and development support for clinical plans and individual study protocols, and playing a key leadership and mentoring role to clinical study teams.
Responsibilities

• Participating in and providing clinical input into safety and regulatory interactions
• Develops statistical plans and performs preliminary and exploratory data analysis of completed clinical trials
• Participates in the development of clinical operating guides and maintains secure study files
• Work closely with Clinical Operations and Clinical Development
• Collaborate with and provide leadership and mentoring to clinical study teams
• Provide clinical/scientific input during the development and execution of clinical trials
• Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)
• Interpret clinical trial data
• Participate in safety assessments
• Review and provide clinical scientific input to TLGs and safety narratives
• Review scientific literature
• Initiate database analyses to support clinical objectives
• Contribute to the preparation of clinical study reports and regulatory submissions
• Participate in interactions with regulatory agencies
• Clinical study report preparation
• Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
• Participate in Development Planning for assigned compounds.
• Oversee and challenges the adequacy of planning for study implementation
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL
• Identify new clinical research opportunities
• Comply with company regulatory, safety and compliance procedures and practices
• May be assigned other projects and duties as required
Qualifications

• PhD/MS/BS degree in a relevant scientific area; in depth understanding of immunology
• 8+ years directly relevant experience in the biotech/pharmaceutical industry including analysis of Oncology Trial data.
• Prior Medical Monitor and Clinical Trial Management experience strongly preferred
• Prior experience in leadership roles for clinical study teams.
• Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Proven scientific leadership when working with collaborative, multi-functional teams.
• Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
• Working knowledge of clinical database systems
• Solid medical/scientific writing skills; ability to effectively communicate across the business organization
• Ability to collaborate and work effectively in cross-functional teams within a complex matrix environment
• Sound scientific and clinical judgment
• Familiarity with regulatory agency organization, guidelines, and practices
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Knowledge of clinical research operations, including interpretation and implementation of cGCP, FDA regulations, and ICH guidelines is required
• Able to deal with time demands, incomplete information or unexpected events
• Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines.
• Ability to travel over night