Scientist/Senior Scientist, Clinical Pathology & IHC

This role requires strong expertise in histology, IHC, and oncology biomarker development, along with the ability to design experiments, interpret complex data, and drive translational strategies from preclinical to clinical stages. The successful candidate will work cross-functionally with pathologists, translational scientists, clinical teams, and external partners to enable biomarker-driven clinical trials, particularly in antibody-drug conjugate (ADC) programs. 

The ideal candidate will have experience bridging preclinical biology, translational science, and clinical biomarker implementation, including support for global regulatory strategies (FDA/NMPA) and CDx co-development. 

This position is full-time onsite at our Redmond, WA location. 

Key Responsibilities 

IHC Assay Development & Validation 

• Develop and optimize IHC assays on FFPE tissues for biomarker and CDx applications 
• Support validation studies in CLIA/CAP and/or GxP environments 
• Perform antibody selection, titration, and qualification 
• Support multiplex IHC/IF development 

Biomarker Strategy & Clinical Integration 

• Contribute to biomarker strategies (e.g., PD-L1, HER2) 
• Support CDx development and clinical implementation 
• Ensure alignment with FDA and NMPA regulatory requirements 

Data Analysis & Interpretation 

• Analyze and interpret IHC results and digital pathology data 
• Collaborate on scoring algorithms and cutoff development 
• Present findings and support scientific and regulatory reporting 

Documentation, Compliance & Collaboration 

• Author SOPs and ensure compliance with CLIA, CAP, and GxP 
• Support audits and inspections 
• Collaborate with internal teams and external partners 

Qualifications 

• PhD with 2–5+ years of experience in biotech, life science, biopharma
• Strong experience with GraphPad, ROC analysis, and biomarker cutoff determination 
• Strong experience in IHC assay development, optimization, and validation 
• Experience supporting clinical trials, translational research, and/or CDx development 
• Demonstrated experience in oncology biomarker development 
• Experience working in regulated environments (CLIA/CAP, GxP) 
• Ability to lead projects and collaborate across multidisciplinary teams 
• Expertise with GraphPad, ROC analysis, and biomarker cutoff determination. Strong data analysis, interpretation, and scientific communication skills
• Expertise in automated IHC platforms (Ventana, Leica, or equivalent) 
• Strong understanding of antibody biology, tumor biology, and tissue-based assays 
• Familiarity with translational biomarker strategies 
• Excellent documentation and quality compliance practices