Seagen

Senior Director Regional Clinical Trial Operations

Development - Bothell, United States

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!

The Sr. Director, Regional Clinical Trial Operations, North America is responsible for leading the North American clinical trial operations, including oversight of Field Monitoring and clinical site partnership programs. This position will take a strategic role in creating and implementing robust clinical trial programs in the assigned region. This position will have responsibility for the oversight of North American clinical trial deliverables across all studies within Seattle Genetics.

Principal Responsibilities:

• Along with the Head, Regional Clinical Trial Operations, establish a strategic vision and long-range plan for the North American RCTO function.
• Determine the best utilization of North American RCTO resources, and the optimal organization of the RCTO infrastructure and staff. Able to leverage experience working in varying resource models (i.e. Hiring, Functional Service Provider, CRO Full Package Outsourcing, etc.).
• Provide leadership and oversight to key site partnerships in North America.
• Make decisions on selecting and managing local RCTO staff as well as external field contractors.
• Responsible for developing and maintaining SOPs and training guides applicable to a global organization.
• Ensure consistency and best practices are followed on all processes, protocols, and within the Clinical Trial Management System (CTMS).
• Take a lead role in managing projects and collaborating globally and across departments such as drug supply, regulatory, data management, biostatistics, medical writing and drug safety.
• Provide local RCTO staff with appropriate coaching, mentoring and development.
• Ensure proper training is implemented to demonstrate to demonstrate GCP/ICH compliance.
• Responsible for quality control plan for the clinical trials site monitoring and management, both for the external field staff and within the internal RCTO staff.

Qualifications:

• Must have significant experience managing global Phase I-IV trials, including trials in North America CRO management, direct CRA management, and project and contract management.
• Must have significant regulatory experience spanning Phase I-IV trials.
• Must have Oncology trial experience.
• Proven ability to effectively manage a large staff comprised of both field and trial management employees.
• Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program.
• Proficiency in GCP/ICH and regulatory issues is essential.
• Excellent communication skills and the ability to proactively handle multiple tasks simultaneously are required.

Education:

• Bachelor’s degree with at least 12 years of pharmaceutical/Biotech clinical development experience.
• An advanced degree (Master’s or PhD) is 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, please 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/16/2022