Director, Regional Clinical Trial Operations
Vor 3 Tagen
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:
- 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
- #LI-LO1_
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