Seagen

Senior Manager Regulatory Project Management

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:

Reporting to the head of Regulatory Project Management, the Sr. Manager 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.

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

Required Qualifications:

• Minimum of 9 years of experience in the biotechnology or pharmaceutical industry
• Minimum of 5 years in drug development, regulatory, or project management functions
• Bachelor’s degree in a scientific discipline or business-related field
• Minimum of 3 years in a project management role

Preferred Qualifications:

• Demonstrated understanding of regulatory and/or drug development execution processes and regulatory requirements for USA, Europe, and Canada, and preferably globally
• Strong experience and proficiency with MS Office and project management systems, such as Microsoft Project and Planisware (preferred)
• Strong experience coordinating interdisciplinary teams, leading project team meetings, cross-functional communication and decision making, and facilitating alignment with internal and external stakeholders in a highly matrixed organization
• Detail-oriented, with strong influence and communication skills, both written and verbal
• Strong organizational and time management skills with ability to think strategically
• Strong customer service skills to enable successful collaboration with stakeholders
• Self-motivated, and able to lead several projects to meet multiple deadlines for complex submission projects and take accountability for project success
• Solutions-oriented with strong problem-solving skills

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 $150,000 - $195,000 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 (with additional annual grants, and grants upon promotion when applicable), 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.

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: 01/13/2023