Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Principal Scientist directing clinical research activities for Neuroscience Medicines. Managing the entire cycle of clinical development at Merck while ensuring compliance and scientific integrity.
Responsibilities
- Manage the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings
- Evaluate pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
- Develop clinical development strategies for investigational or marketed Neuroscience drugs
- Plan clinical trials (design, operational plans, settings)
- Monitor and manage the conduct of ongoing or new clinical trials
- Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications
- Participation in internal and joint internal/external research project teams
Requirements
- M.D or M.D./Ph.D.
- Minimum of 3 years of clinical medicine experience
- Minimum of 3 -5 years of industry experience in drug development or biomedical research experience in academia
- Demonstrated record of scientific scholarship and achievement
- A proven track record in clinical medicine and background in biomedical research is essential
- Strong interpersonal skills, as well as the ability to function in a team environment, are essential.
- Board Certified or Eligible in Neurology or Psychiatry
- Prior specific experience in clinical research and prior publication
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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