Associate Director/Director, Translational BiomarkersNew

Immunome • Bothell, WA

409d • $162,000 - $237,000

About The Position

The Associate Director/Director, Translational Biomarkers at Immunome is responsible for leading clinical biomarker activities to support drug development programs in oncology. This role involves serving as a biomarker representative on study teams, developing biomarker plans for trials, and ensuring the timely collection and analysis of biomarker data. The successful candidate will collaborate with various stakeholders to drive the clinical biomarker development process and support decision-making for clinical-stage programs.

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

Nice To Haves

• Experience with developing, leading, and executing translational biomarker strategies
• Experience with establishing robust validation plans and executing validation studies
• Demonstrated experience supporting clinical development of biomarkers and companion diagnostics
• Excellent problem-solving skills
• Outstanding interpersonal and communication skills (written and oral)
• High level of initiative and ability to work independently

Responsibilities

• Designs and implements program-specific early and late development biomarker plans
• Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation
• Directs the development, outsourcing, and validation of clinically applicable companion diagnostic assays for Phase 1 through registrational studies
• Provides expertise to development project teams to ensure access to state-of-the-art thinking on appropriate diagnostic technologies
• Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
• Aids in the creation of clinical protocols, SAPs, SOWs, lab manuals, and interfaces with CROs for execution of services
• Prepares and delivers internal and external translational biomarker presentations
• Keeps up-to-date on relevant scientific/technical literature and technologies
• Participates in post-hoc biomarker analysis and publication efforts
• Supports regulatory submissions and regulatory interactions as needed

Benefits

• Competitive salary
• Equal opportunity employer
• Commitment to diversity and inclusion

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree