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:

This in-house position is responsible for site start-up activities and includes coordination, management, and oversight of site start-up for two or more clinical studies. This position includes indirect management of staff within the study start-up team.
Principal Responsibilities:

• Accountable for site start-up for 2 or more clinical studies
• Serves as primary point of contact and escalation for site start-up on assigned clinical studies
• Holds start-up Kick Off Meeting with SSU Manager EU, PL, CCM, Legal, and other key stakeholders
• Holds weekly start-up meetings with SSU Manager EU, PL, CCM, Legal, and other key stakeholders as necessary
• Forecasts and tracks progress of site start-up, ensuring all sites on assigned clinical trials are greenlit on time per SSU timelines
• Escalates site issues to appropriate Clinical Study Team members
• Attends Clinical Study Team Meetings through start-up
• Prepares and updates start-up packets for clinical studies
• Assigns sites to SSU Specialists, and manages SSU Specialist and SSU Assistant workload for assigned studies
• Ensures SSU Specialists collect, review, and track essential documents, and review ICFs in accordance with Seagen processes and timelines
• Responsible for reviewing greenlight packets and greenlighting sites
• Ensures SSU team members are properly trained on site start-up activities and kept current on timelines, contract and budget status, and study updates for assigned clinical studies
• May be responsible for sending start-up packets, reviewing ICFs, collecting essential documents, and helping sites with IRB/IEC submissions for one or more clinical sites
• May include the following indirect management responsibilities:
• Problem-solving clinical team personnel issues
• Manages dotted line SSU Specialists and SSU Assistants. Providing timely feedback to SSU Team staff on personal and project-specific performance.
• Trains and mentors junior SSU Team members

Required Qualifications:

• BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years of relevant clinical trial experience
• Minimum of 3 year clinical trial management or equivalent start up unit management experience
• Thorough knowledge of clinical start-up process and requirements
• Thorough knowledge of CFR and GCP/ICH requirements
• Requires effective organizational and time management skills
• Able to multi-task under limited direction and on own initiative
• Strong communication and inter-personal skills
• Ability to coordinate work cross-functionally with diverse teams
• Highly responsive and proactive, a team player

Preferred Qualifications:

• Experience managing large teams (direct or dotted line reporting)
• Oncology clinical research experience
• CRO Oversight
• Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint

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.

The hiring pay range for this position is $107,000 - $138,600 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.

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.
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