Senior Scientist Translational Pathology Biomarker Testing Laboratory (TPBTL)

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: 

Seagen is seeking a Senior Scientist, Translational Pathology Biomarker Testing Laboratory (TPBTL) Operations, as part of the Clinical Biomarker and Diagnostics (CBDx) Team within the Seagen Translational Sciences organization. The CBDx Team functions to generate, implement, and execute biomarker strategies for Seagen’s drug programs that have progressed to clinical development. CBDx collaborates cross-functionally with other areas of Seagen as well as with external partners to achieve goals that are critical for drug development. 

The Senior Scientist, Translational Pathology Biomarker Testing Laboratory (TPBTL) Operations will play a key role in efficient assay transfers from other parts of the organization, assay development and assay optimization and analytical validation for the development of robust prototype assays, using immunohistochemistry and in situ hybridization, and other technologies, in the broader context of precision medicine and multi-plex, multi-technology, testing modalities.  

 

Principal Responsibilities: 

  • Utilizing the technologies including but not limited to Molecular Pathology, Genomics, Immunochemistry, In-Situ Hybridization and Next Gen Sequencing, the Senior Scientist, Translational Pathology Biomarker Testing Laboratory (TPBTL) Operations, is responsible for development and optimization and validation of clinical biomarker assays in all therapeutic areas and in all phases of clinical development. The Senior Scientist will deploy histopathology-based biomarker assays such as singleplex immunohistochemistry and multiplex techniques to inform pipeline decisions for early and late phase clinical trials of all therapeutic areas, with a focus on Oncology 
  • We are seeking a highly motivated Senior Scientist with a doctoral degree (PhD/MD/PharmD) who has a strong knowledge of histopathology-based biomarker assays and their role in drug and assay development process 
  • Candidate must possess scientific excellence and a strong understanding of clinical biomarkers, the ability to work independently with internal and external collaborators within a highly matrixed organization, and excellent written and verbal communication skills to be able to clearly communicate scientific objectives and interpret data. The candidate should also have a strong interest in Translational Sciences and Precision Medicine. This individual will have a critical role in overseeing the histopathology-based clinical assay development, analytical validation, and clinical sample analysis to predict the likelihood of response to treatment and/or better understand the biological mechanisms of disease and therapeutic resistance for supporting our company’s early and late phase clinical trials in close collaboration with other Research and Development Teams 

 

Key Responsibilities 

  • Serve as a subject matter expert in tissue-based and liquid-based assay development and validation, including robust prototype assay development, clinical trial assay development, and potential CDx development, collaborating with research, project teams, biomarker leads, external partners, and others on the implementation of these assays in clinical trials 
  • Lead clinical development and analytical validation of histopathology-based (e.g., immunohistochemistry, multiplex, in-situ hybridization), NextGen Sequencing, and other assays for all therapeutic areas and all phases of clinical development 
  • Assist in the transfer of biomarker assays from Research, Development, and other business areas by providing technical guidance on fit-for-purpose assay validation, and transfer of robust prototype assays to 3rd parties for potential CDx development 
  • Deploy histopathology-based and other assays to external vendors for supporting our company's clinical trials on a global scale and for potential CDx development, provide scientific oversight on clinical sample analysis ongoing at these vendors by ensuring assay and data quality over time, and troubleshoot potential issues efficiently 
  • Serve as subject matter expert in the scientific qualification of new vendors 
  • Interface with scientists and physicians in early and late-stage clinical development to execute biomarker strategies in clinical trials 
  • Write memos, final reports, and publications summarizing data, and writing/updating lab SOPs 

Required Qualifications:   

  • Doctoral degree (Ph.D./PharmD/MD) in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry 
  • Ph.D./MD/PharmD with at least 3 years of post-doctoral training experience 
  • A minimum of 5 years of experience in histopathology-based assay development and validation such as monoplex and multiplex immunohistochemistry (IHC), in-situ hybridization (ISH), and basic knowledge of morphology in histopathological samples 
  • Must have a strong understanding of clinical biomarkers 
  • Strong interpersonal, verbal, and written communication skills 
  • Must be able to work independently with strong leadership skills 
  • Ability to execute and thrive within a matrixed organization 
  • Being self-motivated and eager to learn and evaluate new technologies 

Preferred Qualifications:   

  • Hands-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development 
  • Broad knowledge of drug development process and translational medicine 
  • Prior experience in the fields of oncology and immuno-oncology 
  • Experience in NextGen Sequencing 
  • Prior experience working in a regulated laboratory setting (e.g., CAP/CLIA) 
  • Experience with Regulated Clinical Bioanalysis 
  • Experience in multiplex tissue-based spatial profiling assays (i.e. multiplex immunofluorescence, multiplex chromogenic immunohistochemistry 
  • Hands on experience in acquisition and analysis of singleplex/multiplex tissue-based assay images and single-cell level high-dimensional data generation/analysis 
  • Experience with image acquisition platforms (e.g., Leica Aperio, Hamamatsu, 3DHISTECH Pannoramic) 
  • Experience with digital image analysis of histopathological samples (H&E and/or IHC stained) by using commercial image analysis software packages (e.g., Visiopharm, HALO, PathAI) 
  • Knowledge of using statistical software packages (e.g., Prism, SPSS) 

 

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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