Principal Scientist, CDx IHC Development

About the Company

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, alongside a robust preclinical pipeline of potential cancer therapeutics in the discovery and IND-enabling stages.

About the Role

We are seeking a Principal Scientist to provide technical leadership for the development of immunohistochemistry (IHC) companion diagnostics (CDx) supporting oncology drug programs. This individual will serve as a subject matter expert responsible for CDx assay strategy, analytical validation, and clinical implementation from early feasibility through regulatory submission and commercialization readiness. This is a hands-on scientific leadership role requiring strong collaboration with pathology, translational science, regulatory, clinical development, and external diagnostic partners to ensure successful CDx execution aligned with therapeutic timelines. This position is full-time onsite at our Redmond, WA location.

Responsibilities

• CDx IHC Kit Development & Strategy
  • 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 (e.g., Ventana, Dako, Leica)
  • Guide development of scoring algorithms, cut-offs, and interpretation frameworks with pathology leadership
• Analytical Validation & Design Control
  • Lead analytical validation strategy and execution for CDx IHC assays, including sensitivity, specificity, precision, accuracy, and robustness
  • Ensure validation activities meet regulatory expectations and are conducted under design control
  • Oversee preparation and approval of validation protocols, reports, and technical documentation
  • Ensure traceability, risk management, and documentation in compliance with QSR 820 and ISO 13485
• Clinical & CDx Implementation
  • Provide oversight for implementation of CDx IHC assays in clinical trials and central laboratories
  • Ensure assay consistency, pathologist alignment, and scoring harmonization across sites
  • Support biomarker strategy, sample plans, and clinical cut-off justification
• Regulatory & Quality
  • Partner with Regulatory Affairs and QA to support CDx regulatory strategy and submissions (e.g., IND/IDE, PMA/IVD)
  • Ensure compliance with global regulatory requirements (FDA, NMPA, IVDR)
  • Support bridging strategies from RUO/LDT to IVD CDx and contribute to regulatory interactions
  • Drive alignment with QMS, including design controls, change control, and audit readiness
• Cross-Functional Leadership
  • Act as subject matter expert for CDx IHC development across internal and external stakeholders
  • Lead collaborations with CROs, central labs, and IVD partners
  • Mentor team members and contribute to building CDx development capabilities

Requirements

• PhD in Pathology, Immunology, Molecular Biology, or related life science field
• 8–12+ years of industry experience in CDx, IVD, or biomarker assay development
• Proven experience leading IHC assay development and analytical validation
• Strong knowledge of design controls and QMS (21 CFR Part 820, ISO 13485)
• Experience supporting clinical trials and CDx regulatory submissions
• Strong understanding of IHC scoring methods (TPS, CPS, H-score)
• Experience working in oncology biomarker development environments

Preferred Qualifications

• Experience with approved or late-stage CDx programs
• Background in oncology biomarkers (e.g., NSCLC, GI cancers)
• Experience interacting with health authorities (FDA, NMPA, EU)

Pay

The expected base salary range for this position is $130,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level, qualifications, experience, and skills.

Benefits

• 100% paid employee premiums for medical, dental, and vision coverage
• Short-term and long-term disability insurance
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of 5 years
• 15 PTO days per year, plus sick leave and 11 paid holidays