Associate Director, Regional Clinical Trial Operations

Clinical Development Operations Seattle, Washington


Description

Summary: 

The Associate 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 team.  This position will take a primary role in providing leadership and oversight of Clinical Trial Managers and Clinical Research Associates. 

Principal Responsibilities:

Project and Management Responsibilities

  • May lead RCTO activities on all phases and complexity of trials from First to Human to Global Phase 3
  • Represents Regional Clinical Trial Operations in senior level, cross-functional teams and committees
  • Reviews molecule and study level documents, such as the protocol, Investigator Brochure, Pharmacy Instructions, Case Report Form and Inform Consent Form
  • Along with the Director, Regional Clinical Trial Operations, establishes a strategic vision and long-range plan for the RCTO team
  • Determines the best utilization and the optimal organization of the RCTO infrastructure and staff
  • Helps build strong Regional Clinical Trial Operations teams and makes decisions on selecting RCTO staff
  • Directly manage a large RCTO team that may include Clinical Trial Managers and Clinical Research Associates
  • Provide RCTO staff with appropriate coaching, mentoring and development
  • Participate in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
  • Serve as Subject Matter Expert in one or more area.  May be internal or external-facing and may be cross-functional
  • Primary contact for CRO’s Clinical Trial Site Monitoring Team.   Oversees CRO’s performance in site management ensuring compliance to the protocol, terms of the contract, CFR, ICH/GCP, and overall quality of work

 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 consistency and best practices are followed on all processes, protocols, and clinical systems, such as within the Clinical Trial Management System (CTMS) and electronic Trial Master File
  • 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

  • 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 11 years of relevant clinical trial management experience.  Advanced degree preferred
  • Must have significant regulatory experience spanning Phase I-III trials, preferring past participation in an NDA or BLA process
  • 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 Managers and CRAs
  • 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 CFR, GCP/ICH and regulatory issues is essential

 Education:

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 11 years of relevant clinical trial management experience.  Advanced degree preferred

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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