Associate Director/Director, CDx IHC Development

Responsibilities

• 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
• 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
• Align with FDA QSR (21 CFR 820), ISO 13485, and design control frameworks
• 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 PMAs
• 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.