Seagen

Director, Regional Clinical Trial Operations

Development - Zug, Switzerland

Description

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.Seagen.com

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.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/16/2022