Data Coordinator II supporting clinical trials research at Winship Cancer Institute. Facilitating data management and ensuring accuracy of clinical trial databases with compliance to protocol guidelines.
About the role
- Senior Principal Scientist managing clinical research activities involving investigational compounds in Immunology. Focusing on late-stage development and comprehensive clinical trial management.
Responsibilities
- Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
- Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline
- Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategies.
- Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs.
- Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and Participation in internal and joint internal/external research project teams relevant to the development of new compounds.
Requirements
- M.D., D.O., M.D./Ph.D, or D.O./PhD
- Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology
- Minimum of 3 years of clinical medicine experience
- Minimum of 5 years of industry experience in drug development
- Demonstrated record of scientific scholarship and achievement
- Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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