Associate Director​/Director, CDx IHC Development

Overview

Syst Immune is a leading and well-funded clinical-stage biopharmaceutical company with locations in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). Syst Immune has assets in various stages of clinical trials for solid tumor and hematologic indications, with a robust preclinical pipeline representing cutting-edge biologics development.

This role is for an Associate Director or Director to provide technical and organizational leadership for immunohistochemistry (IHC) companion diagnostic development supporting oncology drug programs. This position requires full-time onsite work in Redmond, WA.

• Lead technical strategy for IHC companion diagnostic development across oncology programs
• Drive assay development from feasibility through IVD readiness
• Ensure CDx timelines align with drug development milestones
• Define technical development plans including assay architecture and validation strategy
• Identify technical risks and implement mitigation strategies
• Act as the technical decision maker for CDx IHC development programs

• Provide scientific oversight of assay design, antibody selection, and staining optimization
• Guide assay troubleshooting and performance improvement strategies
• Review experimental design and validation approaches
• Interpret analytical validation data and define acceptance criteria
• Guide development of scoring strategies with pathologists
• Ensure scientific rigor in assay development activities
• Remain technically engaged in CDx development rather than operating solely as a program leader

• Directly manage scientists and research associates
• Recruit, hire, and develop CDx technical staff
• Provide performance management and career development guidance
• Establish team goals and development priorities
• Build CDx technical capabilities aligned with company growth
• Foster a high accountability, execution focused culture
• Mentor scientists in both technical and professional development

• Oversee analytical validation strategy and execution
• Ensure compliance with design control requirements
• Ensure alignment with FDA QSR (21 CFR 820) and ISO 13485
• Review validation protocols, reports, and technical documentation
• Partner with QA to support inspections and audits
• Ensure proper risk management and traceability practices

• Lead CDx implementation strategy for clinical trials
• Partner with Regulatory Affairs on CDx submission strategy including IND, IDE, and PMA
• Support regulatory interactions and technical responses
• Contribute to global regulatory strategy including FDA, IVDR, and NMPA
• Support transition from RUO/LDT assays to IVD companion diagnostics
• Ensure diagnostic strategy supports precision medicine objectives

• Lead CDx collaborations with CROs, central labs, and diagnostic partners
• Serve as CDx SME across internal development teams
• Influence cross functional strategy discussions
• Manage external vendors and partnerships
• Present CDx strategy, risks, and progress to senior leadership
• Contribute to long term CDx capability planning

• PhD in Pathology, Immunology, Molecular Biology, or related life sciences field
• 10 to 15+ years of industry experience in companion diagnostics, IVD, or oncology biomarker development with demonstrated progression of responsibility
• Deep hands-on experience developing IHC companion diagnostic assays including assay design, optimization, analytical validation, and clinical implementation
• Proven technical ownership of CDx programs, including authoring or reviewing validation strategies, interpreting technical data, and guiding scientific decisions
• Strong experience operating within regulated diagnostic environments including FDA QSR (21 CFR 820), ISO 13485, and design control frameworks
• Experience supporting CDx regulatory strategy and submissions including IND, IDE, or PMA preferred
• Strong…