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Medical Director

Employer
CTI Clinical Trial Services
Location
Cincinnati, Ohio
Salary
Medical Director
Closing date
Jun 23, 2022

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Job Purpose / Summary: Responsible for medical monitoring for clinical trials and providing scientific and medical expertise for consulting projects, and staff members, in accordance with any applicable CTI Standard Operating Procedures (SOPs).

 

Essential Functions:

  • Act as Medical Monitor for all clinical trials based on scope of project
  • Interact with FDA and other regulatory agencies
  • Review and manage all serious adverse events (SAEs) during course of clinical trials, and participate in managing SAE reporting
  • Participate in clinical trial study conference calls
  • Contact investigators and coordinators involved in studies
  • Provide training for staff and serve as medical resource 
  • Provide medical guidance to regulatory and scientific affairs projects, including but not limited to protocols, IND’s, regulatory documents, clinical study reports, NDA’s and BLAs
  • Provide medical guidance to real world evidence projects, including but not limited to protocols, patient populations, identifying key thought leaders
  • Collaborate with multiple team members to ensure medical accuracy in scientific writing projects
  • Participate in advisory boards and training programs
  • Serve as mentor to team members and clients
  • Support Business Development for all CTI departments by providing Medical Expertise and Guidance, attending capabilities meetings, bid defenses, conferences and client meetings as necessary 
  • Identify potential areas of business development and client expansion

Competencies:

  • Proficient with technology, including Excel, PowerPoint, and Word
  • Knowledge of GCP and ICH guidelines

Required Education/Experience:

  • 2 years in the pharmaceutical, biotech, or CRO industry
  • Medical degree, clinical practice, participation / conduct of clinical trials and research
  • Board certified in chosen area of medical specialization

Preferred Education/Experience:

  • 5 years in solid tumor - Oncology
  • Experience leading cross-functional teams
  • FDA experience
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