Senior Director, Clinical Operations

The successful candidate will supervise, design and help write protocols, case report forms and informed consent forms for clinical trials.  The candidate will also supervise and direct the design, implementation, and monitoring of clinical trials, preparation of integrated medical reports, INDs, periodic reports New Drug Applications (NDAs) and Biological License Applications (BLAs), etc. Makes decisions on recruitment/selection of new investigators, contract research organizations and outside vendors. Directs planning and implements all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. May co-monitor at site visits pre-study, at site initiation, at regular intervals during the study and at study closeout. Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Also responsible for reviewing and tracking study budget.

Requirements:

Requires degree in a scientific or health care field (e.g., nursing, pharmacy, physician’s assistant) and 8+ years’ experience (or doctorate degree and 5+ years’ experience) in the pharmaceutical industry including clinical study management experience 

Additional Requirements:

  • Collaborative and strategic-minded
  • Exceptional verbal and written communication skills
  • Proficiency in Word, Excel, and PowerPoint
  • Ability to prioritize, maintain a positive attitude and thrive in a fast-paced and changing environment
  • Ability to travel
  • High attention to detail and demonstrated ability to work well under pressure

Please send your CV/resume with cover letter to info@aravive.com