Associate Director/Director, Biomarker Operations

Role Summary

Associate Director/Director, Biomarker Operations at Syndax Pharmaceuticals to support multiple clinical trials and manage PK and translational biomarker deliverables, including overseeing specialty lab vendors and daily operations in collaboration with Clinical colleagues.

Responsibilities

• Lead and manage the Biomarker Ops group to align on priorities, timelines, deliverables, and communications for Translational Biomarker Plans across trials.
• Oversee weekly/daily operational activities around central and specialty labs to facilitate start-up activities and readouts on Phase 1-3 Trials.
• Serve as central support for the clinical team; primary contact for sites and CROs regarding kitting, sample collections, and handling.
• Author relevant sections of Lab manuals and SOPs for sample collections, processing, and handling of patient samples.
• Initiate and finalize contracts/SOWs; manage vendors and POs; approve invoices for each study in support of objectives and biomarker goals.
• Coordinate data and sample analysis, data transfers, data reconciliation, and data review with internal teams and external vendors.
• Monitor and report key deliverables and timelines for partner labs or CROs responsible for sample handling or analysis.
• Participate in CTWGs and maintain communication with clinical operations regarding study objectives and activities.
• Manage Managers, resources, and workload of Biomarker Ops group.
• Develop and manage internal databases of Biomarker Sample Inventories and Data to facilitate translational analyses.
• Maintain repository of Translational Biomarker Assay documents, including validation reports, SOPs, vendor contracts, sample requirements, and costs.
• Coordinate with Translational colleagues on priorities, timelines, and outputs for external research collaborations; identify and ship samples to vendors/collaborators; manage communications on sample expectations and data transfers.

Qualifications

• 8+ years of experience in biomarker operations, clinical sample management, or translational research in biotech/pharma.
• Proven track record in managing specialty lab vendors and clinical sample logistics.
• Strong understanding of clinical trial processes, GCP, and regulatory requirements.
• Excellent project management, organizational, and communication skills.
• Experience with database systems for sample tracking and data management is a plus.
• Leadership experience with direct reports and cross-functional teams.

Skills

• Biomarker operations and translational research
• Vendor management and contract administration
• Clinical sample handling and lab operations
• Project management and cross-functional collaboration
• Data coordination, data transfers, and data reconciliation

Education

• Degree in life sciences or related field preferred

Additional Requirements

• Location: New York, NY