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Associate Director, Clinical Operations

Reference Number: 2899
Location: East Coast

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

The Associate Director, Clinical Operations will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD.  The span of activities is broad covering clinical activities in late drug development, registration/submission and post registration product maintenance phases and will include local and global working.  The role is to lead and manage defined clinical deliverables across a broad range of activities.  This can include the responsibility to lead complex components of a clinical program such as Life Cycle Management, clinical submission activities, or indication development responsibilities or lead independent work packages or maintenance projects.  Tasks involve project planning and operational delivery of clinical programs, and project management of the scope, schedule and budget.  In addition to clinical work in drug projects, the incumbent may manage improvement or change projects in other business areas.

Major tasks and responsibilities will include:

  • Leads a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk (e.g. large studies/package of studies, submission planning, regulatory defense, inspection readiness, payer evidence).
  • Responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans in agreed systems.
  • Provides input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols.
  • Leads a large/complex work package or manages a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, CROs, vendors and Academic Research Organizations).
  • Acts as operational interface with external partners for externally managed/outsourced studies as appropriate.
  • Ensures timely compliance with companywide governance controls.
  • May be assigned responsibility for leadership and program/project management of non-drug project work.

We seek candidates with the following qualifications:

  • Bachelor’s degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.  Advanced degree is preferred.
  • At least 10 years of experience working in the pharmaceutical industry or similar large multinational organization.
  • Extensive knowledge of clinical operations, project management tools and processes.
  • Proven experience of clinical development / drug development process in various phases of development and therapy areas.
  • Proven ability to learn by working in multiple phases, TAs and/or different development situations.
  • Experience leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
  • Project management certification is desirable but not mandatory.
  • Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory.

 

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 2899. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.