Associate Director Regulatory Affairs Companion Diagnostics

Development Bothell, United States


Description

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:  

The Associate Director, Regulatory Affairs, Companion Diagnostics will work across Seagen’s oncology pipeline as a subject matter expert in the development of global regulatory strategy(s) that incorporate the co-development and registration of a diagnostic. This role requires an experienced and innovative leader capable of developing and executing regulatory diagnostic strategy under US, EU and other major market laws and regulations. 

Principal Responsibilities:  

  • Acts as the Diagnostics Regulatory Expert as part of Global Regulatory Teams across the Seagen pipeline, from early-stage to life-cycle management projects 
  • Assesses and executes co-development diagnostic regulatory strategy for the companion diagnostic (including but not limited to IUO, IVD and CDx) to support global clinical development objectives including post-market approvals 
  • Serve as a regulatory subject matter expert in the interface with IVD manufacturers and provide oversight as part of the established partnership governance 
  • Plan and execute meetings with regulatory agencies that include diagnostic partners and internal diagnostics and drug development teams 
  • Identify risks, gaps, or delays in the CDx development programs and propose mitigation strategies 
  • Monitor the evolving regulatory and competitive landscape for diagnostics; analyze the impact of legislative and regulation changes impactful to Seagen’s products; in collaboration with RPI, collect, evaluate, and disseminate relevant updates 
  • Contribute to Companion Diagnostic Regulatory Policy initiatives working with Regulatory Policy group and participate in meetings with trade associations, patient advocacy groups and health authorities 

Qualifications:  

  • Bachelor’s degree or equivalent in a scientific discipline. Advanced degree preferred 
  • 10+ years’ experience in regulatory affairs within the biotech or pharmaceutical industry including 5+ years’ experience in companion diagnostic regulatory affairs. Oncology experience desirable 
  • Understanding of co-development involving complex diagnostic devices or diagnostic testing services based on biomarkers 
  • Experience with health authority engagement including FDA (CDER and CDRH) and EMA as well as prior relationships with Notified Bodies. Experience with Japan and China a plus 
  • Deep understanding of global regulations and guidance governing companion diagnostics in all phases of development, including post-marketing 
  • Excellent negotiation skills across levels within an organization and with external stakeholders 
  • Experience in working with strategic partners/cross company collaborations. 
  • Ability to manage multiple projects 
  • Excellent collaboration and relationship building skills 
  • Outstanding written and oral communication 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.  

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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