Description

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 ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

We are seeking a Scientist or Senior Scientist to lead and support immunohistochemistry (IHC) assay development for companion diagnostic (CDx) kits supporting oncology drug development. This role is responsible for end-to-end IHC assay development, including antibody selection, assay optimization, analytical validation, and clinical trial implementation, with a clear development path from RUO/LDT to IVD CDx commercialization.

The ideal candidate has strong expertise in pathology, IHC assay development, and CDx regulatory expectations, and can work effectively across R&D, clinical, regulatory, QA, and external CROs and central laboratories.

Key Responsibilities

IHC Assay & CDx Development

Lead development of IHC-based CDx assays, from biomarker discovery through assay optimization and validation.
Select and evaluate primary antibodies, detection systems, and staining platforms (e.g., Ventana, Dako, Leica).
Optimize assay parameters, including epitope retrieval, antibody dilution, detection chemistry, and staining conditions.
Establish scoring algorithms, cut-off strategies, and interpretation guidelines in collaboration with pathologists.
Support biomarker strategies for patient selection and stratification in clinical trials.

Analytical Validation & Performance

Design and oversee analytical performance studies, including:
- Sensitivity and specificity
- Precision and reproducibility (intra-run, inter-run, inter-site)
- Accuracy and robustness
- Linearity and limit of detection, where applicable
Prepare, review, and approve validation protocols, reports, and SOPs in alignment with CDx expectations.

Clinical Trial & Central Lab Support

Support implementation of IHC assays in clinical trials, including:
- Central laboratory qualification and oversight
- Pathologist training and alignment
- Slide logistics, staining consistency, and scoring harmonization
Collaborate with clinical teams on sample strategy, feasibility studies, and biomarker cut-off justification.
Regulatory & Quality Collaboration
Work closely with Regulatory Affairs and Quality Assurance to ensure compliance with:
- FDA CDx guidance (US)
- NMPA/CDE requirements (China), where applicable
- IVDR (EU), as relevant
Support preparation of regulatory documentation, including:
- IDE/IND biomarker sections
- CDx bridging strategies (RUO/LDT → IVD)
- Analytical and clinical performance summaries
Ensure assay development aligns with QMS requirements, design controls, and document traceability.

Cross-Functional & External Collaboration

Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development

Description

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