Senior Director, Clinical Biomarker Operations

The Opportunity:

Revolution Medicines is seeking a strategic and experienced leader to serve as Senior Director, Clinical Biomarker Operations, responsible for leading the operational execution of biomarker and companion diagnostic (CDx) strategies across early- and late-stage clinical development programs. This role will oversee end-to-end biospecimen workflows, including vendor contract setup, oversight, and sample shipments in support of precision oncology clinical trials. The position will lead a team and partner cross-functionally with Clinical Operations and Clinical Development to ensure successful collection of biospecimens for clinical biomarker and CDx testing. This role is a people leader role with organizational impact.

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-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.

Required Skills, Experience and Education:

• 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.

• Proven 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.

Preferred Skills:

• 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.

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