Lead CDx IHC Scientist for Oncology Biomarkers

SystImmune; Redmond (WA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

100% paid employee premiums for health

PTO 15 days

11 paid holidays

Job summary

SystImmune is seeking a Principal Scientist to provide technical leadership for CDx IHC companion diagnostics in oncology. This role focuses on assay strategy, analytical validation, and clinical implementation from early feasibility through regulatory submission and commercialization readiness.

The candidate will lead complex CDx IHC development initiatives, ensure compliance with global regulatory and quality standards, and influence biomarker strategy through deep technical expertise.

Qualifications

• PhD required with deep expertise in CDx IHC development and validation.
• Experience leading IHC assays and analytical validation for regulatory submissions.
• Strong collaboration across pathology, translational science, regulatory, and clinical development teams.

Responsibilities

• Lead development of IHC-based CDx assays and kits from early feasibility through IVD readiness.
• Define assay design, platform selection, and development strategy aligned with CDx regulatory expectations.
• Oversee antibody selection, assay optimization, and standardization across platforms (Ventana, Dako, Leica).
• Guide development of scoring algorithms, cut-offs, and interpretation frameworks with pathology leadership.

Skills

IHC development

Analytical validation

Regulatory submissions

Cross-functional leadership

CDx strategy

Education

PhD in Pathology, Immunology, Molecular Biology, or related life science field

Tools

Ventana

Dako

Leica

Job description

SystImmune is seeking a Principal Scientist to provide technical leadership for CDx IHC companion diagnostics in oncology. This role focuses on assay strategy, analytical validation, and clinical implementation from early feasibility through regulatory submission and commercialization readiness.

The candidate will lead complex CDx IHC development initiatives, ensure compliance with global regulatory and quality standards, and influence biomarker strategy through deep technical expertise.