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Coastal Search Associates, LLC
Published
October 16, 2016
Category
Job Type
Key SKill
Job Qualifications: MD required with Board Certification in Internal Medicine or Surgery; sub- specialty training in Hematology or Gastroenterology preferred - 3 - 5 years of clinical research in a pharmaceutical environment; will consider candidates with prior early or later phase experience - Study-specific experience in the areas of liver disease and blood disorders including Thrombocytopenia are highly preferred
No of Openings
2
experience
5-10

Description

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

 Director, Clinical Research- Neurology 

 Overview:

You will be responsible for the clinical development of Therapeutics in
patients with liver disease. The project is currently in Phase III with multiple, pivotal clinical trials, both of which need to be conducted by an experienced MD. You will serve as
the Medical Monitor for these studies in addition to assuming the role of overall Clinical Lead for the program which includes preparation of registration dossiers for the US, EU and Japan,
and subsequent communications/meetings with Health Authorities as well as preparations for Advisory Committee Meetings to support the submission. The Director will be expected to
work effectively and collaboratively with a co-development partner to meet contractual obligations and project timelines.

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 with Board Certification in Internal Medicine or Surgery; sub- specialty training in Hematology or Gastroenterology preferred
- 3 - 10 years of clinical research in a pharmaceutical environment; will consider candidates with prior early or later phase experience
- Study-specific experience in the areas of liver disease and blood disorders including Thrombocytopenia are highly preferred

  • 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