Senior Clinical Project Manager Details

Senior Clinical Project Manager

Seagen - Bothell, WA

Employment Type : Full-Time

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:

A Sr. Clinical Project Manager (Sr CPM) is responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report. They manage the process and people involved though matrix reporting. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors. The role requires active involvement, to meet schedules or resolve problems or conflicts, and entails frequent interaction with subordinates, outside customers, functional peer groups at various management levels and senior management. Gaining project team cooperation, conducting presentations of technical information concerning specific projects and schedules and solving technical problems, are keys to success.

Principal Responsibilities:

Specific duties are outlined below but are not limited to:

• Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs
• Responsible for leading clinical trial team meetings. May manage the GDT meeting and perform all required cross-functional follow-up
• Creates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget
• Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to track and manage a project’s progress
• Reviews study metrics for performance and quality with the team and management
• Negotiates and manages competing priorities across multiple functional areas
• Manage and coordinate all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each
• Prepares high-quality reports (financial, project, etc.) for management on program status and issues
• Provide early CPM support (i.e., resource needs, feasibility, protocol writing, etc.) for a study concept until a study CPM is formally assigned to a clinical trial
• Provide content for governance meetings on study budgets, timelines, and operational feasibility
• Clinical operations counterpart in partner alliance programs
• Provide senior level operational review of protocols and other critical documents in the clinical trials

Qualifications:

• Highly effective organizational and communication skills
• Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred
• Demonstrated leadership skills and the ability to solve problems proactively
• Willingness to travel approximately 10%
• Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus
• Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company
• Project Management Certification (PMP) is a plus

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties and requirements.

Education:

• BA/BS or equivalent is preferred with a minimum of 8 years of pharmaceutical or biotech research experience

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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