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Study Director

Department: R&D/Excelsior Labs
Type: Full-Time Regular
Location: Madison, WI


Summary

Excelsior Labs is a CRO providing exceptional in vivo drug discovery research services to biotech and pharmaceutical sponsors engaged in pre-clinical drug development. Excelsior Labs enables sponsors to remain science focused by delivering high quality and reliable in-vivo services and data. The Study Director will contribute to the development, growth, and optimization of Excelsior’s premier lab operation. Applicants should be comfortable in a fast-paced and highly collaborative environment. The successful candidate will be an independent self-starter with an intellectual curiosity and a commitment to quality.

Essential Duties and Responsibilities

  • Primary role is as a Study Director for non-GLP studies
  • Single point of contact responsible for the scientific, technical, and regulatory conduct of studies, as well as the interpretation of data and results
  • Leads all internal and external study-related meetings
  • Responsible for regular sponsor communication regarding study design and conduct
  • Monitors the status of studies, including completion of work and scope changes
  • Reviews data for completeness. Identifies and works with operational staff to resolve deficiencies
  • Maintains current knowledge of standard operating procedures, capabilities, and applicable regulatory guidelines such as AAALAC, USDA, AWA 
  • Proficient in project management concepts and tools
  • Manage external vendor relationships
  • Responsible for protocol development and report writing
  • Creates study schedules and leads onboarding for new studies
  • Builds a trusted working relationship with sponsors, delivering excellent customer service that leads to repeat business
  • Coordinates with the operations team to meet reporting deadlines and program milestones
  • Provides regular updates to sponsors and leadership team regarding study progress
  • Assists leadership team to identify and develop new business ventures

Education/Experience/Skills

  • PhD or DABT preferred, MS degree in an appropriate scientific discipline with a minimum of 5 years drug discovery or CRO experience required
  • Exceptional knowledge of oncology research, PDX murine models, ADME, and immunology
  • Previous data interpretation and report writing experience
  • Working knowledge of data analysis and statistical software
  • Experience with client management and technical expertise in drug discovery and early drug development
  • Strong time management and organization skills
 

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