Systimmune

Develops bispecific antibodies and ADCs

Associate Director/Director - CDx IHC Development

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours

Full-timeBothell, WA, USA$150k - $230k /yr

About the Job

Requirements

A PhD in Pathology, Immunology, Molecular Biology, or a related life sciences field is required.
10 to 15+ years of industry experience in companion diagnostics, in vitro diagnostics, or oncology biomarker development, with demonstrated progression of responsibility.
Deep hands-on experience developing immunohistochemistry companion diagnostic assays, including assay design, optimization, analytical validation, and clinical implementation.
Proven technical ownership of companion diagnostic programs, including authoring or reviewing validation strategies, interpreting technical data, and guiding scientific decisions.
Strong experience in regulated diagnostic environments, including FDA Quality System Regulation (21 CFR 820), ISO 13485, and design control frameworks.
Strong technical expertise in immunohistochemistry scoring methodologies, including TPS, CPS, and H-score, and experience working with pathologists on scoring strategy.
Demonstrated experience managing and developing scientists, including hiring, mentoring, and performance management.
Experience leading companion diagnostic programs supporting oncology clinical trials and precision medicine strategies.
Strong cross-functional leadership experience working with clinical development, translational science, regulatory, quality, and external diagnostic partners.
Associate Director candidates typically bring 10+ years of experience with prior people management; Director candidates typically bring 12–15+ years, including functional or multi-program leadership.

Responsibilities

Lead technical strategy for immunohistochemistry companion diagnostic development across oncology programs.
Drive assay development from feasibility through in vitro diagnostic readiness.
Ensure companion diagnostic 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 companion diagnostic immunohistochemistry 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 companion diagnostic development rather than operating solely as a program leader.
Directly manage scientists and research associates.
Recruit, hire, and develop companion diagnostic technical staff.
Provide performance management and career development guidance.
Establish team goals and development priorities.
Build companion diagnostic technical capabilities aligned with company growth.
Mentor scientists in technical and professional development.
Oversee analytical validation strategy and execution.
Ensure compliance with design control requirements.
Ensure alignment with FDA Quality System Regulation (21 CFR 820) and ISO 13485.
Review validation protocols, reports, and technical documentation.
Partner with Quality Assurance to support inspections and audits.
Ensure proper risk management and traceability practices.
Lead companion diagnostic implementation strategy for clinical trials.
Partner with Regulatory Affairs on companion diagnostic 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 research-use-only and laboratory-developed tests to in vitro diagnostic companion diagnostics.
Ensure diagnostic strategy supports precision medicine objectives.
Lead companion diagnostic collaborations with contract research organizations, central labs, and diagnostic partners.
Serve as the companion diagnostic subject matter expert across internal development teams.
Influence cross-functional strategy discussions.
Manage external vendors and partnerships.
Present companion diagnostic strategy, risks, and progress to senior leadership.
Contribute to long-term companion diagnostic capability planning.

Desired Qualifications

Experience supporting companion diagnostic regulatory strategy and submissions, including IND, IDE, or PMA.
Experience working with major diagnostic platforms such as Ventana, Dako, or Leica.
Experience with approved or late-stage companion diagnostic programs.
Background in oncology biomarkers, such as non-small cell lung cancer or gastrointestinal cancers.
Experience interacting with health authorities, including FDA, NMPA, or EU authorities.

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, 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 Bothell, WA.

Responsibilities
CDx Technical Strategy and Execution

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

Hands-On Technical Leadership

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

People Leadership and Team Development

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

Analytical Validation and Quality Systems Leadership

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

Clinical and Regulatory Leadership

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

Cross Functional and External Leadership

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

Qualifications

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 technical expertise in IHC scoring methodologies including TPS, CPS, and H-score and experience working with pathologists on scoring strategy
Demonstrated experience managing and developing scientists, including hiring, mentoring, and performance management
Experience leading CDx programs supporting oncology clinical trials and precision medicine strategies
Strong cross-functional leadership experience working with clinical development, translational science, regulatory, quality, and external diagnostic partners
Experience working with major diagnostic platforms such as Ventana, Dako, or Leica strongly preferred
Associate Director candidates typically bring 10+ years of experience with prior people management; Director candidates typically bring 12–15+ years including functional or multi-program leadership

Preferred Qualifications

Experience with approved or late-stage CDx programs
Background 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.

About the Company

Systimmune

Develops bispecific antibodies and ADCs

Systimmune is a biopharmaceutical company that develops antibody-based cancer therapies, including bispecific and trispecific antibodies and antibody-drug conjugates (ADCs). These products are designed to act on the solid tumor micro-environment to directly attack tumors and/or to activate the immune system to fight cancer. The company uses multiple immuno-oncology platforms and experienced scientists to create biologics that intervene in the tumor environment in systematic ways. Compared with competitors, Systimmune emphasizes integrating several antibody-based modalities (bispecifics, trispecifics, and ADCs) and a deep focus on the solid tumor micro-environment, aiming to translate biological insight into targeted, immune-engaging therapies. The goal is to produce biologics that effectively modulate the tumor environment and mobilize the body's own immune response to destroy cancer cells.

Company size: 11-50
Company stage: Not listed
Total funding: Not listed
Headquarters: Redmond, WA
Founded: 2014

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