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.

#LI-SH1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

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.

Base Pay Salary Range

$244,000-$305,000 USD

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.

Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

If you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.