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

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. In addition to 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. SystImmune offers 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. 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 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 Qualifications Education PhD in Pathology, Molecular Biology, Immunology, Oncology, or a related field MS or BS with significant CDx or IVD industry experience may be considered Experience 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 Soft Skills 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 non‑technical stakeholders Experience working with global teams is a plus Preferred Qualifications Prior experience with late‑stage or FDA‑approved CDx programs Experience developing and justifying biomarker cut‑off strategies Familiarity with NSCLC, GI cancers, or other solid tumors Experience interacting with health authorities or supporting regulatory meetings Why Join Us Opportunity to shape next‑generation CDx programs linked to innovative oncology therapeutics High‑visibility role with direct impact on patient selection and drug approval Collaborative environment bridging pathology, translational science, and regulatory strategy Compensation and Benefits The expected base salary range for this position is $90,000 – $140,000 annually. Actual compensation will be based on a variety of factors, including but not limited to the candidate’s qualifications, level of the position, experience, and skills. While most offers typically fall within the low to mid‑point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune offers a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply. #J-18808-Ljbffr SystImmune