Senior Director, Clinical Operations

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

Major tasks and responsibilities include:
  • Leads the clinical operations team in the execution of the clinical development plan for an exciting, potential “best in class” drug for the treatment of ulcerative colitis.
  • Provides oversight of clinical trial operations with regards to planning, development, execution, and reporting, and may directly manage complex clinical studies.
  • Directs the clinical operations team in the efficient and high-quality execution of studies while ensuring compliance with GCP, SOPs and applicable regulations.
  • Manages resources, timelines and budgets.
  • Directs personnel activities, manages resource distribution and provides guidance for professional development of staff.
  • Coordinates with cross-functional departments to facilitate negotiation/issue resolution for clinical trial related challenges.
  • Contributes to the development and implementation of internal policies & procedures to optimize the management of clinical trials.
  • Identifies risks and mitigations and implements corrective action plans.
  • Manages external CROs and vendors.
  • Manages and mentors clinical operations team, as well as addresses talent gaps and development opportunities.
We seek candidates with the following qualifications:
  • A Bachelor’s Degree is required. An advanced degree is preferred.
  • Requires 12+ years of pharmaceutical industry experience.
  • Must have 10+ years of experience working in clinical operations or related area.
  • Must have demonstrated leadership of clinical operations and/or clinical development teams across all phases of clinical development.
  • Requires Proficient knowledge of the drug development process, Health Authority regulations and ICH technical aspects of clinical study conduct.
  • Must have the ability to act as a change agent through inspirational leadership aligning activities to business and corporate goals.
  • The ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner is required.
  • The ability to interpret and develop a variety of instructions furnished in written, oral, diagram, or schedule form is required.
  • Must have strong follow-up and organizational skills.
  • Must be able to identify situations which require intervention for resolution.
  • The ability to maintain confidentiality is required.
If interested, please apply directly to this job posting. 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.
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