Associate Director, Biomarker Development

Role Summary

The Department of Research and Translational Medicine is seeking an Associate Director, Biomarker Development. This person will lead the development of biomarker strategies and execution for clinical development of programs in inflammatory and immune indications across the Apogee development pipeline.

Key Responsibilities

• In this role, you will work across functions in Translational Research and Clinical Biomarkers to design, prioritize and execute biomarker strategies for clinical programs in I&I indications.
• Distil and communicate biomarker plans, rationale, concepts and findings to internal stakeholders at appropriate levels for different audiences. Ability to execute in a highly matrixed model where strong communication and partnership skills are critical to success.
• Work closely with clinical operations, biomarker operations, medical and clinical development leads in driving the program to the clinic including finalization of lab manuals by providing input to specimen handling, collection, shipping and storage guidelines, set up sample testing timelines and oversee data transfers.
• Lead the development and implementation of assays using flow cytometry, immunoassays, proteomics, and genomics-based tools for inclusion in clinical trials. Partner closely with Biomarker Operations and Biomarker Laboratory members to drive optimization and execution of assays.
• Collaborate with Research, Biomarker Lab team and Biomarker Operations to assess method feasibility and supervise assay transfer to CROs; design and oversee experiments to troubleshoot assay performance issues.
• Establish relations with CROs, or academic laboratories, to execute biomarker strategy, monitor assay development including qualification/validation and biomarker testing in clinical trials to ensure high quality biomarker data.
• Analyze and interpret biomarker data generated across multiple platforms, in conjunction with biostats and computational biologists, to provide guidance on program impact and next steps.