Director Regional Clinical Trial Operations, Europe

Seagen (Zug ZG, Schweiz) Vor 4 Tagen veröffentlicht

Position Summary:

The Director, Regional Clinical Trial Operations is a critical role responsible for leading the Regional Clinical Trial Operations (RCTO) team in trial execution of all trials within a molecule or therapeutic area and in helping build the strategic vision of the European team. This position will take a primary role in providing leadership and oversight of late development programs.

Principal Responsibilities:

Project and Management Responsibilities

  • Will provide leadership to European Regional Clinical Trial Operations project teams to ensure delivery of early and late phase project milestones
  • Represents Regional Clinical Trial Operations in senior level, cross-functional teams and committees
  • Ensures consistency across project teams
  • Along with the Sr. Director, Regional Clinical Trial Operations, establishes a strategic vision and long-range plan for the European RCTO team
  • Works globally to determine the best utilization and the optimal organization of the European RCTO infrastructure and staff
  • Provides RCTO staff with appropriate coaching, mentoring and development
  • Provides guidance in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
  • Serves as Subject Matter Expert in one or more areas. May be internal or external-facing and may be cross-functional
  • May be a point of escalation for CRO’s performance in site management

Infrastructure Development and Maintenance

  • Develops new or leads the improvement of existing department systems and processes
  • Leads the implementation of process improvements or of new process across RCTO
  • Develops or improves SOPs and training guides applicable to a global organization
  • Ensures proper training is implemented to demonstrate CFR, GCP/ICH compliance
  • Participates in the selection of vendors and Contract Research Organization (CRO) services as required

Qualifications:

  • BA/BS or equivalent and a minimum of 12 years of relevant clinical trial management experience
  • Advanced degree (Masters, PharmDs, etc) and 8+ years of experience will also be considered
  • Must have significant clinical trial experience spanning Phase I-III trials, preferring strong background in all phases of trials
  • Must have significant experience managing global trials
  • Oncology trial experience preferred, or experience with trials in similar disease states
  • Proven ability to effectively manage a large staff of clinical trial professionals, specifically Clinical Trial Managers
  • Intense drive and exceptional organizational expertise are necessary to manage the diverse group of functional activities Ability to proactively handle multiple tasks simultaneously are required
  • Proficiency in GCP/ICH and regulatory issues is essential
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit [...] is an equal opportunity employer. All qualified applications will receive consideration for employment.

Director Regional Clinical Trial Operations, Europe

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