Senior Director, Clinical Biomarker Operations

About the role

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.
• #LI-SH1 #LI-Hybrid
• Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
• Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/

Benefits

Additional Information

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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