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Director, Clinical Development

Reference Number: 3198
Location: Remote

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for a Director, Clinical Development.

Major tasks and responsibilities will include:

  • Assists in the development and execution of high-quality, cross-functional, clinical trial plans and serve as training and a support resource to the Clinical Operations team.
  • Works cross functionally with members of pharmacology, discovery, safety, marketing, regulatory, research and other teams.
  • Provides information on resource requirements to Project Management, Clinical Operations and other groups as required.
  • Assists in scientific oversight of both vendors and investigators to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
  • Provides information to regulatory affairs and cross-functional teams as required to support submissions and reports.
  • Supports the development and contribute to documents submitted to the FDA, EMA and other regulatory bodies.
  • Works with Drug Safety leaders and IRB’s to troubleshoot any relevant issues, and keep team members advised of progress, issues and results.
  • Creates study synopses and support and provide input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, and GCP.
  • Works with external experts as needed to develop quality clinical programs, study designs, and data interpretation. 
  • Works with study statisticians and outside statistical consultants to ensure studies are appropriately powered to provide interpretable data at study conclusion.
  • Ensures clinical projects/programs are tracked and communicated to appropriate functional groups in a consistent and timely manner.
  • Helps in the development and preparation of study manuscripts for intended publication.
  • Contributes to preparations/slide decks for periodic DMC meetings.

We seek candidates with the following qualifications:

  • A minimum of 15 years of clinical design and operation experience in the pharmaceutical or biotechnology industry is a must.
  • Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in clinical research within a pharmaceutical or biotech environment.

 

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 3198. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.