Associate Director/Director, Translational Biomarkers

1 week ago

Bothell, Washington, United States Immunome Inc Full time
Job Title: Associate Director/Director, Translational Biomarkers

Immunome Inc. is a clinical-stage targeted oncology company dedicated to developing innovative therapies for cancer patients. We are seeking an experienced Associate Director/Director, Translational Biomarkers to join our team.

Job Summary:

The Associate Director/Director, Translational Biomarkers will be responsible for leading clinical biomarker activities to support our drug development programs in oncology. This individual will design and implement program-specific early and late development biomarker plans, determine appropriate assays and vendors for clinical biomarkers, and manage outsourcing of biomarker assay development and validation.

Key Responsibilities:
  • Design and implement program-specific early and late development biomarker plans
  • Determine appropriate assays and vendors for clinical biomarkers, and manage outsourcing of biomarker assay development and validation
  • Direct the development, outsourcing, and validation of clinically applicable companion diagnostic assays for Phase 1 through registrational studies
  • Provide expertise to development project teams to ensure access to state-of-the-art thinking on appropriate diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status, and any technical or statistical issues related to the proposed companion diagnostic assay
  • Manage clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
  • Responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manuals, and interfacing with CROs for execution of services
  • Prepare and deliver internal and external translational biomarker presentations
  • Keep up-to-date on relevant scientific/technical literature and technologies in order to apply external knowledge to internal biomarker and companion diagnostic development as appropriate and collaborate within the team to guide indication and patient selection
  • Participate in post-hoc biomarker analysis and publication efforts
  • Support regulatory submissions and regulatory interactions as needed
Requirements:
  • Bachelor's, Master's, or Ph.D. degree in a Life Sciences field
  • A minimum of 12 years of industry experience (or 10+ years with a Master's degree, or 8+ years with a doctoral degree) in clinical biomarkers
  • Experience with immunohistochemistry (IHC) assay development and validation
  • Experience in clinical oncology biomarkers and diagnostics as well as awareness of the challenges of implementing diagnostic technologies in the clinical setting
Skills/Knowledge Required:
  • Experience with developing, leading, and executing translational biomarker strategies, such as the transition from discovery research into clinical development
  • Experience with establishing robust validation plans and executing validation studies to demonstrate the clinical utility, analytical validity, and reproducibility of biomarkers
  • Demonstrated experience supporting clinical development of biomarkers and companion diagnostics
  • Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment
  • Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly
  • High level of initiative and ability to work independently
Equal Employment Opportunity:

Immunome Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Salary:

$162,000 - $237,000

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