SM/AD, Clinical Biomarker CDx Operations

About the role

The Senior Manager/Associate Director, Clinical Biomarkers & CDx Operations will lead biospecimen operations across Avenzo clinical programs. This role requires deep knowledge and experience in biomarker operations and clinical sample workflows to enable high-quality, analyzable biomarker data across clinical studies.

Responsibilities

• Manage clinical biomarker samples operations, including collection, processing, shipment, storage, analysis, data delivery, and final disposition; oversee interactions with CROs, central labs, diagnostic partners, biomarker vendors, biorepositories, couriers and kit providers, and drive issue escalation as needed
• Own chain-of-custody, labeling standards, reconciliation, deviations, and CAPA processes for biospecimens, including systematic root-cause analysis and prevention
• Enable robust data flow and traceability by coordinating vendor deliverables (e.g., manifests, accessioning logs, LIMS exports, assay result files) and ensuring timely, high-quality transfer to Avenzo systems/partners
• Support the evaluation and selection of biomarker assays, diagnostic technologies and external vendors to support drug development programs
• Ensure compliance with regulatory requirements for diagnostic tests and precision medicine approaches used in clinical studies, including drafting Standard Operating Procedures (SOPs) to maintain high quality standards and reviewing information consent forms (ICFs) to ensure regulatory compliance
• Guarantee inspection-ready operations consistent with applicable GxP/GCLP principles, internal procedures, and vendor quality agreements; support audits and inspections as needed
• Prioritize effectively to deliver results within established timelines and budgets, partner with Finance/Procurement on contracting and invoice/PO processes as applicable

Requirements

• Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS.) with 8+ years of experience in biomarker operations, clinical sample operations, central lab operations, clinical laboratory services, or biomarker operations
• Strong working knowledge of clinical research operations and expectations for sample handling integrity, traceability, and documentation; experience supporting clinical trials preferred
• Strong understanding of the drug development process and how diagnostic development can inform clinical strategy and commercialization is preferred
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Preferred Qualifications

• Experience in global study start-up activities for clinical trials
• Strong understanding of the drug development process and how diagnostic development can inform clinical strategy and commercialization is preferred
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Physical Demands and Work Environment

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights
• On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously