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Clinical Science Director
Confirmed live in the last 24 hours
Locations
United States
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
Leadership
Management
Research
Writing
Requirements
  • Ph.D. in a relevant scientific area with 8+ years of industry experience in the biotechnology or pharmaceutical industry or a combination of academia and industry
  • Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the design of study protocols is required
  • Direct experience coordinating trial activities, in clinical sample management and biomarker analysis
  • Proven scientific leadership when working with collaborative, multi-functional teams
  • Excellent technical writing and communication skills; able to articulate sophisticated scientific concepts to diverse functional groups and external partners
  • Proven experience authoring submissions documents to regulatory agencies
  • Knowledge of clinical outcome assessments (COAs) and experience working with COA / Rater vendors highly desirable
  • A history of strong collaboration and personal interaction with all levels of internal partners including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, Non-clinical Science, and Product Development
  • Highest level of scientific integrity
  • Strong digital literacy including MS Office (Word, Excel
Responsibilities
  • The Director of Clinical Science will ensure alignment between strategy and study protocols, operational structure, and operating procedures
  • You will be responsible for ongoing data analysis, summarizing study results for the preparation of documents and publications, and supporting project teams with scientific information and progress updates related to the assigned clinical studies
  • Other responsibilities will include leading the development of clinical development-related documents including study synopses and protocols, investigational brochures, clinical study reports, and documents that support the development and execution of clinical studies
Alector

51-200 employees

Company Overview
Alector is combining state-of-the-art antibody technology and recent discoveries in neuroimmunology and human genetics to develop novel.