Senior Director, Clinical Biomarker Operations

Revolution Medicines•Redwood City, CA

1d•Hybrid

About The Position

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.

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.
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.

Nice To Haves

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.

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.