Seattle Genetics

Regulatory Project Manager

Description

Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) uses the company’s industry-leading antibody-drug conjugate (ADC) technology and is approved for the treatment of multiple CD30-expressing lymphomas.

Beyond ADCETRIS®, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing or planned pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer use our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors.

Summary

Seattle Genetics is seeking a highly motivated Project Manager who will be responsible for managing and coordinating the late stage research through clinical development Global Regulatory Teams within Regulatory Affairs. This position serves as an essential partner of and support for the Global Regulatory Lead, and as a liaison between the Regulatory Affairs team members and senior management.

Responsibilities:

• Managing and coordinating regulatory team meetings, and preparing agendas, recording meeting minutes and tracking action items.
• Develop, maintain, track, and manage high-quality program timelines, dashboards, team sites and the Regulatory Submission Request information when required, to enable accurate team reporting and decision making.
• Use project knowledge and facilitation to enable effective teams and meetings.
• Communicate and present program status, issues and opportunities to stakeholders.
• Identify critical path issues, risks, resource needs and alternative scenarios to achieve objectives.
• Manage team-level and corporate processes effectively, using strong project and process knowledge to drive team deliverables.
• Apply project management expertise, methodologies, and department standards.
• Contributes to the functional excellence of Regulatory project management by participation in the development and continuous improvement of processes, procedures, and tools related to program and portfolio management practices.

Requirements:

• Requires a BS degree, advanced degree preferred, in life sciences or business-related field.
• Minimum of 4 years in a project management function, and 2 years in a pharmaceutical or biotechnology environment.
• Demonstrated understanding of Regulatory and/or drug development processes.
• Excellent customer service skills, which enable successful collaboration with stakeholders.
• Strong organizational, project and time management skills.
• Effective communication skills, both written and verbal.
• Takes accountability for all project management aspects and works collaboratively with team leader.
• Expert use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
• Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders.
• Sound judgment, problem solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems.
• Solutions-oriented with strong problem-solving skills.
• Ability to work effectively with cross-functional teams in a highly matrixed organization.
• Demonstrated experience coordinating interdisciplinary teams.
• Experience with MS Office programs, and Microsoft Project (preferred).

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics 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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Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 09/20/2019