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Director, Clinical Operations

Reference Number: 4252
Location: USA - remote

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

Major tasks and responsibilities will include: 

  • Provides operational leadership to internal/external resources for late phase clinical trials to achieve company objectives.
  • Manages and oversees Contract Research Organizations (CROs)/vendors.
  • Leads CRO operational teams in the generation and delivery of quality recruitment plans and risk mitigation strategies.
  • Monitors trial progress.
  • Ensures active management and implementation of risk mitigation strategies and engagement of CROs.
  • Continuously assesses CRO resources and resolves CRO performance issues.
  • Oversees study management compliance activities and ensure inspection readiness.
  • Effectively manages clinical operations activities.
  • Leads the operational team to analyze and deliver quality feasibility of clinical programs and protocols.
  • Ensures the collection of high-quality clinical data.
  • Supports and/or participates in the analysis of clinical data.
  • Develops clinical trial forecasts for budget based on resource requirements.
  • Provides oversight of clinical drug supply.
  • Provides drug supply forecasts based on clinical trial requirements.
  • Serves as the Subject Matter Expert (SME) on study protocol and operations.
  • Ensures proper training and education to internal and external resources.
  • Develops and manages internal and external clinical site monitoring activities for clinical trials on a global level.
  • Effectively communicates clinical trial updates.
  • Works in a collaborative manner with cross-functional personnel to accomplish agreed upon deliverables by driving organizational best practices.
  • Contributes to the establishment of study timelines and critical milestones.
  • Champions the implementation and use of harmonized, consistent processes and excellence in study management deliverables related to cost effective, timely and high-quality clinical trial data.
  • Participates in interdepartmental scientific and medical activities specific to implementation and conduct of clinical protocols.
  • Manages clinical operations colleagues, consultants and CROs in variety of roles.
  • Other responsibilities as assigned by the supervisor.

We seek candidates with the following qualifications:

  • Bachelor’s and/or Master’s degree in a scientific discipline required.
  • Must have a minimum 10+ years of clinical operations experience in the pharmaceutical or biotechnology industry.
  • Requires a minimum of 5 years of experience in a project-lead or leadership capacity.
  • Must have experience in study management, monitoring, and pharmaceutical business.
  • Working knowledge of the processes required to operationally execute clinical trials required.
  • Requires strong understanding of FDA regulations, GCP, ICH guidelines and clinical research SOPs.
  • Must have the demonstrated capability to proactively manage vendor-supplied resources including experience in site monitoring.
  • Experience with protocol development is highly preferred.

If interested, please email your resume as a Word attachment to us, reference 4252.  No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.