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

 Director, Clinical Research- Alzheimer's

 Overview:

Director, Clinical Research Alzheimer's will have MD or PhD degree and mid-level experience in the pharmaceutical

industry. The position is intended to provide the organization with a qualified individual to design and to oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and Alzheimer’s Disease. You will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring

Responsibilities include but are not limited to:

1. Directing and implementing Clinical research plans and programs per 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 required
• 3-5 years of experience depending upon credentials, in pharmaceutical clinical research or clinical scientific background, preferably with experience in neuroscience and especially dementia (e.g., Alzheimer’s disease)

• 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