Senior Director, Clinical Biomarker Operations

Responsibilities

• Oversee planning and execution of operational strategies for clinical biomarker development and CDx across multiple clinical-stage programs.
• Partner with Clinical Biomarker Development team in Translational Medicine to operationalize testing of samples using state-of-the-art molecular assays; e.g., next-generation sequencing (NGS) of circulating tumor DNA (ctDNA) and tumor tissues.
• Partner with Precision Medicine & CDx team in Translational Medicine to implement testing for patient selection/stratification and clinical validation for regulatory submissions.
• Collaborate with Clinical Operations and Clinical Development teams to integrate biomarker and CDx strategies into study protocols, informed consent forms, and lab manuals.
• Partner with Biospecimen Management to establish and maintain robust sample tracking systems, chain-of-custody procedures, and reconciliation processes to ensure data integrity and audit readiness.
• Identify risks and implement mitigation strategies to ensure successful execution of biomarker and CDx deliverables.
• Build, mentor, and lead a high-performing clinical biomarker operations team.

Requirements

• Bachelor’s, Master’s, or PhD degree in life sciences or a related field.
• Minimum of 15 years of experience in biomarker operations, clinical operations, or translational research within biotechnology or pharmaceutical industry.
• Demonstrated experience leading biospecimen operations in phase 1 and global phase 3 clinical trials.
• Strong understanding of biospecimen management and global clinical trial logistics.
• Experience managing external vendors, including central labs and testing labs.
• Knowledge of GCP, GLP, and regulatory requirements related to biospecimen handling.
• Prominent leadership experience managing teams and cross-functional initiatives.
• Strong problem-solving skills with the ability to manage complex operational challenges.
• Excellent written and verbal communication and interpersonal skills.
• Ability to operate effectively in a fast-paced, collaborative, and innovative environment.

Qualifications

• Advanced degree (Master’s or PhD) with relevant experience in oncology.
• Experience supporting regulatory submissions involving CDx tests.
• Familiarity with a broad range of biomarker assays (NGS of ctDNA and tumor tissues).
• Prior experience building or scaling clinical biomarker operations functions in a rapidly growing organization.

Skills

• Strategic and experienced leader.
• People leader role with organizational impact.

Benefits

Base Pay Salary Range: $244,000 - $305,000 USD

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