Seagen
Director Regional Clinical Trial Operations
Development - Bothell, United States
Description
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
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(s) or therapeutic area(s) and in helping build the strategic vision of the 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 Regional Clinical Trial Operations project teams to ensure delivery of 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 RCTO team
- Works globally to determine the best utilization and the optimal organization of the 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 Seagen 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 late 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 Managers
- Intense drive and exceptional organizational expertise are necessary to manage the diverse group of functional activities. Ability to proactively handle multiple tasks simultaneously
- 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 12 years of relevant clinical trial management experience. Advanced degree preferred
As the leading employer in our industry in the Pacific Northwest, 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. 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 Seagen, visit www.seagen.com.
Seagen 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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 07/29/2022
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