Position at Seagen 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: Reporting to the head of Regulatory Project Management, the Associate Director of Regulatory Project Management (RPM) provides project management leadership for the regulatory group and manages several regulatory projects directly. This position will support the Global Regulatory Leads (GRLs) and Global Regulatory Teams (GRTs) to enable the successful coordination and execution of program activities. This position may directly manage other team members or contractors. Principal Responsibilities:
Provide the necessary project management support for the GRT and meet time-sensitive regulatory commitments aligned with internal governance and product team goals
Manages the regulatory project activities for early-stage clinical and late-stage marketed products
Partner with the Global Regulatory Lead and liaise between the GRT members and senior management
Develop, maintain, track, and manage high-quality program timelines, dashboards, and team sites to enable accurate team reporting and decision making
Identify critical path issues, risks, resource needs and alternative scenarios to achieve objectives
Communicate and present program status, issues, and opportunities to stakeholders, including product teams, management, and governance
Tracks, manages, and coordinates information requests from regulatory agencies
Assures Regulatory Affairs and the GRTs follow Seagen project management requirements and appropriately anticipates changes to remain in compliance
Manage team-level and corporate processes effectively, using strong project and process knowledge to drive team deliverables
Use strong project and organizational knowledge, leadership, and active facilitation to enable effective team meetings and high-performance teams
Collaborate across the organization to develop, maintain, track, and manage high-quality, integrated project plans to enable accurate reporting and decision making
Manages the effective, efficient and complaint use of Planisware system and processes for the management and archive of all GRT project plans
Hire, coach, mentor, develop, and manage performance of team members to maximize their contributions and personal growth
At least 12 years of experience in the biotechnology or pharmaceutical industry, including at least 8 years in drug development, regulatory, or project management functions
Bachelor's degree in a scientific discipline or business-related field
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 visitwww.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.