The Cardiovascular and Respiratory Clinical Research Director has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and respiratory medicines. Our Company's cardiovascular and respiratory medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.
Requirements
- Three years clinical medicine experience
- One year industry experience in drug development or biomedical research experience in academia
- Demonstrated record of scientific scholarship and achievement
- Proven track record in clinical medicine and background in biomedical research
- Board Certified or Eligible Cardiologist or Endocrinologist/Lipidologist
- Prior specific experience in clinical research and prior publication.
- Academic Presentations
Responsibilities
- Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and investigational new drug applications
- Creating clinical development strategies for investigational or marketed cardiovascular and respiratory drugs
- 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 or marketed cardiovascular and respiratory drugs
- Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
- Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
- Supervise the activities of Clinical Scientists in the execution of clinical studies
Other
- Work independently and as a team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
- Strong interpersonal skills, as well as the ability to function in a team environment
- Travel on company business about 20% of the time to manage future or ongoing clinical research projects
- M.D or M.D./Ph.D.
- Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects