Scientist/Senior Scientist, Companion Diagnostics; CDx – IHC Development
Listed on 2026-01-16
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Science
Medical Science, Data Scientist
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 tumour and haematologic indications, alongside a robust preclinical pipeline in the discover and IND‑enabling stages.
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 optimisation, analytical validation and clinical trial implementation, with a clear development path from RUO/LDT to IVD CDx commercialisation.
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 optimisation 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 harmonisation
- Collaborate with clinical teams on sample strategy, feasibility studies and biomarker cut‑off justification.
- 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 life‑cycle (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 skills
- Ability to operate in a fast‑paced, matrix environment
- Clear and effective communication with both technical and…
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