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Director Clinical Research

Reference Number: 3193
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for a Director, Clinical Research.

Major tasks and responsibilities will include:

  • Directs and implements clinical research plans and programs according to established design principles.
  • Directs the integration of the CDP and DDP.
  • Leads the development of the Clinical Protocols to meet CDP objectives.
  • Serves as a Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data.
  • Serves as the Medical Monitor and Study Director for a study or clinical program to review and monitor study safety data.
  • Implements strategies to identify monitor and resolve clinical program/trial issues.
  • Serves as 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.
  • Interprets study data and develops the integrated summaries of safety and efficacy.
  • Contributes clinical expertise and content to regulatory documents.
  • May represent Clinical in discussions with Health Authorities.

We seek candidates with the following 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.
  • In-depth knowledge of drug development principles and clinical trial execution is required.
  • Experience conducting global clinical trials and basic knowledge of regulatory requirements is required.
  • Prior experience communicating with and presenting to Regulatory Authorities on study/program design strategy and analysis of results as they relate to filings and clinical trials is preferred.
  • Prior partnership experience in drug development is highly desirable.
  • The ability to lead the complexities associated with co-development efforts and work cross functionally with a collaborative style that builds alliances and emphasizes the company’s Core Values in a fast paced environment.
  • The ideal candidate is persuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3193. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.