Associate Director/Director, 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. 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.SystImmune is seeking an experienced Associate Director or Director to provide technical and organizational leadership for immunohistochemistry (IHC) companion diagnostic development supporting oncology drug programs. This role requires deep hands-on expertise in CDx assay development combined with strong people leadership experience.This is a technical leadership role requiring a candidate who has personally developed, optimized, and advanced IHC CDx assays and can guide scientific decision making based on direct experience. The successful candidate will operate as a player-coach, leading scientists while remaining technically engaged in assay strategy, validation, and regulatory readiness.This individual will lead CDx development from early biomarker feasibility through clinical implementation and regulatory submission while ensuring compliance with global quality and regulatory standards. The role will partner closely with translational medicine, pathology, clinical development, regulatory, and external diagnostic partners to ensure CDx programs successfully support therapeutic approvals.This position requires full-time onsite work in Redmond, WA.ResponsibilitiesCDx Technical Strategy and ExecutionLead technical strategy for IHC companion diagnostic development across oncology programsDrive assay development from feasibility through IVD readinessEnsure CDx timelines align with drug development milestonesDefine technical development plans including assay architecture and validation strategyIdentify technical risks and implement mitigation strategiesAct as the technical decision maker for CDx IHC development programsHands-On Technical LeadershipProvide scientific oversight of assay design, antibody selection, and staining optimizationGuide assay troubleshooting and performance improvement strategiesReview experimental design and validation approachesInterpret analytical validation data and define acceptance criteriaGuide development of scoring strategies with pathologistsEnsure scientific rigor in assay development activitiesRemain technically engaged in CDx development rather than operating solely as a program leaderPeople Leadership and Team DevelopmentDirectly manage scientists and research associatesRecruit, hire, and develop CDx technical staffProvide performance management and career development guidanceEstablish team goals and development prioritiesBuild CDx technical capabilities aligned with company growthFoster a high accountability, execution focused cultureMentor scientists in both technical and professional developmentAnalytical Validation and Quality Systems LeadershipOversee analytical validation strategy and executionEnsure compliance with design control requirementsEnsure alignment with FDA QSR (21 CFR 820) and ISO 13485Review validation protocols, reports, and technical documentationPartner with QA to support inspections and auditsEnsure proper risk management and traceability practicesClinical and Regulatory LeadershipLead CDx implementation strategy for clinical trialsPartner with Regulatory Affairs on CDx submission strategy including IND, IDE, and PMASupport regulatory interactions and technical responsesContribute to global regulatory strategy including FDA, IVDR, and NMPASupport transition from RUO/LDT assays to IVD companion diagnosticsEnsure diagnostic strategy supports precision medicine objectivesCross Functional and External LeadershipLead CDx collaborations with CROs, central labs, and diagnostic partnersServe as CDx SME across internal development teamsInfluence cross functional strategy discussionsManage external vendors and partnershipsPresent CDx strategy, risks, and progress to senior leadershipContribute to long term CDx capability planningQualificationsPhD in Pathology, Immunology, Molecular Biology, or related life sciences field10 to 15+ years of industry experience in companion diagnostics, IVD, or oncology biomarker development with demonstrated progression of responsibilityDeep hands-on experience developing IHC companion diagnostic assays including assay design, optimization, analytical validation, and clinical implementationProven technical ownership of CDx programs, including authoring or reviewing validation strategies, interpreting technical data, and guiding scientific decisionsStrong experience operating within regulated diagnostic environments including FDA QSR (21 CFR 820), ISO 13485, and design control frameworksExperience supporting CDx regulatory strategy and submissions including IND, IDE, or PMA preferredStrong technical expertise in IHC scoring methodologies including TPS, CPS, and H-score and experience working with pathologists on scoring strategyDemonstrated experience managing and developing scientists, including hiring, mentoring, and performance managementExperience leading CDx programs supporting oncology clinical trials and precision medicine strategiesStrong cross-functional leadership experience working with clinical development, translational science, regulatory, quality, and external diagnostic partnersExperience working with major diagnostic platforms such as Ventana, Dako, or Leica strongly preferredAssociate Director candidates typically bring 10+ years of experience with prior people management; Director candidates typically bring 12-15+ years including functional or multi-program leadershipPreferred QualificationsExperience with approved or late-stage CDx programsBackground in oncology biomarkers (e.g., NSCLC, GI cancers)Experience interacting with health authorities (FDA, NMPA, EU)Compensation and Benefits:The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's level qualifications, 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 is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Created: 2026-04-15