Associate Director/Director, CDx IHC Development

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.