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Associate Director Clinical Operations

Reference Number: 3155
Location: Mid-West

Our client is a leading and rapidly growing pharmaceutical company.  They have asked us to assist them in their search for an Associate Director Clinical Operations.

Major tasks and responsibilities will include:

  • Assists the Sr. Director in managing the operational execution of the clinical development plans and in the management of Clinical Operations.
  • Manages staff that is supporting the Centers of Expertise (CoEs) in operational roles.
  • Manages the Clinical Operations staff to plan and execute clinical studies for more than one compound including early development activities, technical transfer activities and abbreviated new drug applications.
  • Leads operational support for the company’s programs in the Center of Expertise group that comprise internal, co-development and externally developed programs.
  • Manages operational teams and outsourced activity for a number of compounds leading to regulatory submission or potential licensing or co-development activities.
  • Manages Clinical Program Managers, Senior Clinical Project Managers, and CRAs/Sr. CRAs.

We seek candidates with the following qualifications:

  • Bachelor’s degree in science related fields. Advanced degree preferred.
  • Has human through phase 3 experience developing and executing a clinical program.
  • Preferred experience in managing clinical study execution globally.
  • 14 plus years for bachelors level, 12 plus years for Masters level and 7 plus years for doctoral  level candidate in medium to large pharmaceutical and/or  4 plus years in biotechnology industry based  clinical research experience;  preferably a minimum of 8 plus years in Clinical Operations.
  • Has 3 plus years’ experience in managing mid-to high level technical staff for clinical operations.
  • Extensive experience in collaborating with CRO staff for the planning and execution of global programs.
  • Has experience in working to set up and executing bioequivalence (BE), bioavailability (BA) studies with project management experience.
  • Significant experience with clinical team management.
  • Demonstrates competency in setting up and managing projects from start to finish within established budgets and timelines. Ideally, has strong project management experience including some knowledge or experience of putting together budget and forecast spreadsheets.
  • Experience in utilization of standardized document management system for using templates for study documents and tracking versions, edits in systematic fashion.
  • Desired- previous experience in compiling data and reports for and NDA.
  • Approximately 30% travel within the continental United States and Globally.

 

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 3155. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.