Seagen
Executive Director Regulatory Centers of Excellence
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:
With an expanding depth and breadth of Regulatory activities we seek an Executive Director, Regulatory Centers of Excellence (COE), reporting to the SVP Regulatory Affairs. The candidate will provide leadership, direction, and strategic guidance to ensure the successful implementation of milestones and goals and to fulfill the commitments of the COE. This role will require strategic thinking around key issues, organizational processes, and procedures, while enabling effective planning and execution. This position is both strategic and facilitative, requiring a willingness to play a very active, behind-the-scenes role, aiding the SVP and Regulatory Senior Leadership Team (SLT) to further fulfil the department’s objectives. This role will ensure initiatives are prioritized appropriately and prepare leadership for upcoming decisions. This role will also oversee four regulatory functions; Advertising and Promotion; Companion Diagnostics; Labeling; and Regulatory Policy and Intelligence.
Principal Responsibilities:
Includes but not limited to:
- Defines strategic initiatives and sets long range goals for the Regulatory organization.
- Provides leadership to four strategic regulatory functions; Advertising and Promotion; Companion Diagnostics; Labeling; and Regulatory Policy and Intelligence.
- Serves as a trusted thought partner to the Head of Global Regulatory Affairs.
- Provides significant subject matter expertise in core development functions given the criticality of aligning cross-functional teams and driving process forward.
- Orchestrates the identification, prioritization, and advancement of initiatives; monitors progress and communicates updates to internal teams and external stakeholders.
- Engages in strategic discussions and provides recommendations based on analysis with quantifiable opportunities to drive optimization.
- Develops and grows relationships with internal stakeholders, including members of DELTa and other Seagen senior leaders in Research, TOPS and Commercial, to facilitate ideation of opportunities and to effectively implement solutions.
- Represents Seagen on external associations (trade, professional, advocacy).
- Partners with HR to support development of team members and departmental optimization by identifying opportunities for increasing employee engagement and satisfaction.
Required Qualifications:
- Strong initiative with the ability to manage simultaneous projects of varying complexity.
- Effective leader with solid interpersonal skills.
- Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation.
- Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
- Handles confidential information with discretion.
- Adept communication skills including ability to concisely summarize complex issues and listen effectively to concerns and problems.
- High standards of excellence and exceptional attention to detail.
- Self-starter who identifies and helps solve problems, and can deal with ambiguity.
- Familiarity and understanding of scientific and clinical principles that guide our business.
- Comfortable challenging the status quo and bringing forward innovative solutions.
- Ability to take risks implementing innovative solutions, accelerating time to market.
Preferred Qualifications:
- Advanced degree (MSc, PhD, PharmD) preferred.
- Excellent organizational, computer and documentation skills.
- Ability to prioritize effectively.
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, 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 07/22/2022
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