My client is a Mid -Size New Jersey Pharmaceutical company.

 Director, Clinical Research-Neuroscience

 Overview:

Director, Clinical Research will design and oversee the conduct of clinical programs/studies for Phase II and III development of compounds targeting neurological
disorders encompassing epilepsy, neuropathic pain and other studies. The Director will provide input into clinical development strategies as well as perform medical monitoring based on
credentials, for these indications and potentially, others.
Responsibilities include but are not limited to:

1. Directing and implementing Clinical research plans and programs according to established design principles.
2. Leading the development of Clinical Protocols to meet objectives
   3. Serving as a Study Director and driving the execution of studies from protocol concept to final report including interpretation of clinical data
   4. Willing to serve as a Medical Monitor and possibly, Study Director for a study or clinical program; including review and monitoring study safety data
   Implementing strategies to identify, monitor and resolve clinical program/ trial issues. Leads the Clinical team.
   5. Serving as a SME to provide direction to all project team functions, Organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program
   strategy and scientific advice

Job Qualifications:

• MD /PHD but MD preferred; Sub-specialty training in Neurology or Psychiatry
• A minimum of 5 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies
• Strong interpersonal and leadership skills; demonstrated ability to build consensus and drive change in a matrix environment with cross functional teams
• A thorough understanding of clinical research methodology including study design, protocol writing, and study report preparation
• Comprehensive understanding of GCP of local regulatory requirements
• Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience
pharmaceutical or biotech industry