Director Regional Clinical Trial Operations

Clinical Development Operations Zug, Switzerland


Description

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 early 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

Leadership & Functional Competencies

  • Ability to collaborate cross-functionally to deliver on portfolio milestones and establish best practices
  • Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations
  • Ability to work successfully in a mid-stage biotechnology culture where a premium is placed on delivering science-based results in an entrepreneurial, fast moving and a sometimes resource constrained environment

Qualifications:

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 12 years of relevant clinical trial management experience. Advanced degree preferred
  • Must have significant clinical trial experience spanning Phase I-III trials, preferring strong background in early phase 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

 

Education:

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 12 years of relevant clinical trial management experience. Advanced degree preferred.

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 www.seagen.com


Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.