ZipRecruiter

Log In

1

Biomarker Operation Manager Jobs in San Ramon, CA

BigHat

Senior Director, Clinical Operations

San Mateo, CA · On-site

$275 - $295/hr

Senior Director, Clinical Operations Department: Drug Development Employment Type: Full Time ... Experience in clinical site‑side sample management and biomarker program support. * Familiarity ...

next page

Showing results 1-20

All JobsBiomarker Operation JobsBiomarker Operation Manager JobsBiomarker Operation Manager Jobs in San Ramon, CA

Biomarker Operation Manager information

What are the key skills and qualifications needed to thrive as a biomarker operation manager?

To excel as a Biomarker Operation Manager, you need a solid background in biomedical sciences or a related field, experience in clinical trials, and a deep understanding of biomarker development and validation. Familiarity with laboratory information management systems (LIMS), regulatory compliance tools, and project management software is typically required. Exceptional organizational, communication, and leadership skills are crucial for coordinating cross-functional teams and managing complex projects. These competencies ensure the timely, compliant, and efficient delivery of biomarker strategies that are critical to successful clinical research and drug development.

What is the difference between Biomarker Operation Manager vs Biomarker Scientist?

AspectBiomarker Operation ManagerBiomarker Scientist
Primary RoleOversees biomarker assay operations, manages teams, ensures quality controlConducts biomarker research, develops assays, analyzes data
Required CredentialsBachelor's or Master's in life sciences, project management experienceAdvanced degree (PhD or Master's), laboratory expertise
Work EnvironmentClinical labs, research organizations, biotech companiesResearch labs, academic institutions, pharmaceutical companies
Industry UsageCommon in clinical trial settings and biotech firmsPrimarily in research and development roles

The Biomarker Operation Manager focuses on managing biomarker assay operations and team coordination, ensuring quality and compliance. In contrast, the Biomarker Scientist is dedicated to conducting research, developing new assays, and analyzing data. Both roles require scientific credentials, but their daily responsibilities and work environments differ significantly.

What are some common challenges faced by a biomarker operation manager when coordinating multi-site clinical trials?

A Biomarker Operation Manager often encounters challenges such as ensuring consistent sample collection and processing across multiple sites, maintaining strict compliance with regulatory standards, and facilitating effective communication between cross-functional teams. Managing logistics for timely shipment and storage of biological specimens, as well as addressing unforeseen protocol deviations, are also key difficulties. Successfully navigating these challenges requires strong organizational skills, attention to detail, and proactive problem-solving to support seamless trial execution.

What does a biomarker operation manager do?

A Biomarker Operation Manager oversees the planning, execution, and management of biomarker studies within clinical trials. They coordinate with cross-functional teams to ensure the proper selection, collection, analysis, and reporting of biomarker data. Their role is crucial in ensuring compliance with regulatory requirements, timelines, and scientific objectives. Biomarker Operation Managers also work closely with external vendors and laboratories to ensure high-quality and timely data delivery, supporting the overall drug development process.
What job categories do people searching Biomarker Operation Manager jobs in San Ramon, CA look for? The top searched job categories for Biomarker Operation Manager jobs in San Ramon, CA are:
What cities near San Ramon, CA are hiring for Biomarker Operation Manager jobs? Cities near San Ramon, CA with the most Biomarker Operation Manager job openings:
Biomarker Operation Manager jobs near you

Senior Director, Clinical Biomarker Operations

Revolution Medicines

Redwood City, CA • Hybrid

Full-time

Re-posted 18 days ago

Job description

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

Apply