Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development
Listed on 2026-07-31
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Research/Development
Research Scientist, Data Scientist, Clinical Research, Immunology Research
Syst Immune 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). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. Syst Immune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development.
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
- 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
- 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
- Serve as a technical subject-matter expert, interacting with:
- CROs, central laboratories, and IVD partners
- Antibody vendors and staining platform providers
- Provide scientific input to project teams, governance meetings, and external collaborations
- Mentor junior scientists and contribute to team capability building, as appropriate
- PhD in Pathology, Molecular Biology, Immunology, Oncology, or a related field
- MS or BS with significant CDx or IVD industry experience may be considered
- 3-5+ years of hands-on experience in IHC assay development, preferably in a CDx or IVD setting
- Direct experience supporting oncology biomarkers and clinical trials
- Experience across the CDx development lifecycle (RUO/LDT through IVD readiness)
- Strong understanding of IHC scoring methodologies (e.g., TPS, H-score, CPS)
- Familiarity with analytical validation and regulatory expectations for CDx
- Demonstrated ability to work effectively in cross-functional teams
- Strong scientific rigor with excellent documentation and data interpretation…
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