Seattle Genetics, Inc. Manager/Sr. Manager, Diagnostics & Biomarkers in Bothell, Washington

Manager/Sr. Manager, Diagnostics & Biomarkers

Clinical OperationsBothell, Washington




The Biomarker Sr. Manager coordinates the planning and implementation of predictive and pharmacodynamic biomarkers in clinical trials and may coordinate development of companion diagnostic tests (IVD). The incumbent will manage, and may lead, internal and external initiatives supporting biomarker development within programs focused on leukemia and other hematologic malignancies.


  • Develops and leads biomarker and patient selection strategies for one or more clinical stage program, collaborating closely with Clinical, Preclinical, and Project Team Leads

  • Coordinates closely with Clinical Project Management to operationalize biomarker and patient selection strategies, including vendor selection, assay development and validation, incorporation of necessary pre-analytical sample requirements in trial Research Specimen Manuals, drafting of appropriate Informed Consent language and ultimately sample analysis

  • In collaboration with Bioinformatics, Data Management, Biostatistics, Medical Monitor and Clinical Lead, develops data transfer and analysis plans, as well as appropriate study reports

  • Collaborates with Clinical Pharmacology to evaluate PK/PD relationships

  • Collaborates with scientists within Seattle Genetics Research and with external vendors to develop pharmacodynamicand patient selection (diagnostic) assays

  • Maintain familiarity with novel biomarker, diagnostic and analytical technologies

  • Assist in forecasting the biomarker operational costs and reviewing biomarker specific invoices


  • PhD, MD or DO degree in a relevant scientific area

  • Pharmaceutical industry experience or familiarity with industry-sponsored clinical trials preferred

  • Technically proficient, practical, collaborative, and quantitative with strong scientific creativity, affinity for technology and strong problem solving skills

  • Familiarity with flow cytometry, PCR, IHC and next-generation sequencing-based analysis of clinical samples

  • Deep understanding of cancer biology; a focus on leukemias is preferred

  • Strong project management skills and ability to work as part of a matrixed team

  • Understanding of clinical operations with the ability to implement well-design experiments within a clinical trial environment

  • Excellent communication and interpersonal skills; able to evaluate and articulate complex scientific and business issues and implement solutions

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.