Partner with Precision Medicine & CDx team in Translational Medicine to implement testing for patient selection/stratification and clinical validation for regulatory submissions. * Collaborate with ...
Partner with Precision Medicine & CDx team in Translational Medicine to implement testing for patient selection/stratification and clinical validation for regulatory submissions. * Collaborate with ...
The remaining 40% will support the CDx business directly, including partnership on deal economics, planning processes, and financial visibility across the business. This structure provides meaningful ...
The remaining 40% will support the CDx business directly, including partnership on deal economics, planning processes, and financial visibility across the business. This structure provides meaningful ...
Director / Associate Director Companion Diagnostics Lead, Translational Sciences
Wilmington, DE ยท On-site
Author CDx related parts across documents * Ensure CDx representation in cross-functional teams * Serve as alliance and project manager between Incyte and key diagnostic partners * Generate and ...
Director / Associate Director Companion Diagnostics Lead, Translational Sciences
Wilmington, DE ยท On-site
Author CDx related parts across documents * Ensure CDx representation in cross-functional teams * Serve as alliance and project manager between Incyte and key diagnostic partners * Generate and ...
Cleveland Diagnostics (CDx) is a fast-growing, venture-backed, commercial-stage biotechnology company developing next-generation diagnostic platforms and products, such as our proprietary IsoClear ...
Cleveland Diagnostics (CDx) is a fast-growing, venture-backed, commercial-stage biotechnology company developing next-generation diagnostic platforms and products, such as our proprietary IsoClear ...
You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality ...
You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality ...
Sr Financial Analyst - Clinical Sequencing Division (CSD)
Carlsbad, CA ยท On-site
$88K - $110K/yr
The remaining 40% will support the CDx business directly, including partnership on deal economics, planning processes, and financial visibility across the business. This structure provides meaningful ...
Sr Financial Analyst - Clinical Sequencing Division (CSD)
Carlsbad, CA ยท On-site
$88K - $110K/yr
The remaining 40% will support the CDx business directly, including partnership on deal economics, planning processes, and financial visibility across the business. This structure provides meaningful ...
Global CDx Study Manager
Indianapolis, IN ยท Hybrid
Labcorp is seeking a Global CDx Study Manager I to join our team at 8211 Scicor Drive, Indianapolis, Indiana . Work Schedule Monday - Friday, day shift Job Responsibilities * Serve as a Diagnostic ...
Global CDx Study Manager
Indianapolis, IN ยท Hybrid
Labcorp is seeking a Global CDx Study Manager I to join our team at 8211 Scicor Drive, Indianapolis, Indiana . Work Schedule Monday - Friday, day shift Job Responsibilities * Serve as a Diagnostic ...
Global CDx Study Manager
Indianapolis, IN ยท On-site
Labcorp is seeking a Global CDx Study Manager I to join our team at 8211 Scicor Drive, Indianapolis, Indiana . Work Schedule Monday - Friday, day shift Job Responsibilities * Serve as a Diagnostic ...
Global CDx Study Manager
Indianapolis, IN ยท On-site
Labcorp is seeking a Global CDx Study Manager I to join our team at 8211 Scicor Drive, Indianapolis, Indiana . Work Schedule Monday - Friday, day shift Job Responsibilities * Serve as a Diagnostic ...
You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality ...
You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality ...
$195K - $391K/yr
Coordinate CDx activities to address Rx expansion to additional indications and geographies. * Drive Agilent as the partner of choice for new opportunities with new stakeholders. * Field customer ...
$195K - $391K/yr
Coordinate CDx activities to address Rx expansion to additional indications and geographies. * Drive Agilent as the partner of choice for new opportunities with new stakeholders. * Field customer ...
Senior Program Manager
Redwood City, CA ยท Hybrid
$142K - $142K/yr
Work closely with CDx Leads and other clinical development team members to facilitate science-based CDx decision making and drive the execution of the CDx development strategy. * Develop and maintain ...
Senior Program Manager
Redwood City, CA ยท Hybrid
$142K - $142K/yr
Work closely with CDx Leads and other clinical development team members to facilitate science-based CDx decision making and drive the execution of the CDx development strategy. * Develop and maintain ...
You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality ...
You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality ...
Cleveland Diagnostics (CDx) is a fast-growing, venture-backed, commercial-stage biotechnology company developing next-generation diagnostic platforms and products, such as our proprietary IsoClear ...
Cleveland Diagnostics (CDx) is a fast-growing, venture-backed, commercial-stage biotechnology company developing next-generation diagnostic platforms and products, such as our proprietary IsoClear ...
Partner with Precision Medicine & CDx team in Translational Medicine to implement testing for patient selection/stratification and clinical validation for regulatory submissions. * Collaborate with ...
Partner with Precision Medicine & CDx team in Translational Medicine to implement testing for patient selection/stratification and clinical validation for regulatory submissions. * Collaborate with ...
Scientist/Senior Scientist, Clinical Pathology & IHC
Redmond, WA ยท On-site
$90K - $140K/yr
Support CDx development and clinical implementation * Ensure alignment with FDA and NMPA regulatory requirements Data Analysis & Interpretation * Analyze and interpret IHC results and digital ...
Scientist/Senior Scientist, Clinical Pathology & IHC
Redmond, WA ยท On-site
$90K - $140K/yr
Support CDx development and clinical implementation * Ensure alignment with FDA and NMPA regulatory requirements Data Analysis & Interpretation * Analyze and interpret IHC results and digital ...
This role leads CDx programs from early development through commercialization while ensuring scientific excellence, operational efficiency, and full regulatory compliance. The position requires deep ...
This role leads CDx programs from early development through commercialization while ensuring scientific excellence, operational efficiency, and full regulatory compliance. The position requires deep ...
This role leads CDx programs from early development through commercialization while ensuring scientific excellence, operational efficiency, and full regulatory compliance. The position requires deep ...
This role leads CDx programs from early development through commercialization while ensuring scientific excellence, operational efficiency, and full regulatory compliance. The position requires deep ...
Scientist/Senior Scientist, Clinical Pathology & IHC
Redmond, WA ยท On-site
$90K - $140K/yr
Support CDx development and clinical implementation * Ensure alignment with FDA and NMPA regulatory requirements Data Analysis & Interpretation * Analyze and interpret IHC results and digital ...
Quick apply
Scientist/Senior Scientist, Clinical Pathology & IHC
Redmond, WA ยท On-site
$90K - $140K/yr
Support CDx development and clinical implementation * Ensure alignment with FDA and NMPA regulatory requirements Data Analysis & Interpretation * Analyze and interpret IHC results and digital ...
Sr. Director, Biostatistics
South San Francisco, CA ยท On-site
$240K - $280K/yr
This position requires extensive experience in oncology drug development, late-stage clinical trial strategy, adaptive designs, biomarker and CDx co-development, and regulatory submissions. The ...
Sr. Director, Biostatistics
South San Francisco, CA ยท On-site
$240K - $280K/yr
This position requires extensive experience in oncology drug development, late-stage clinical trial strategy, adaptive designs, biomarker and CDx co-development, and regulatory submissions. The ...
Senior Program Manager
Redwood City, CA ยท On-site
$142K - $142K/yr
Work closely with CDx Leads and other clinical development team members to facilitate science-based CDx decision making and drive the execution of the CDx development strategy. * Develop and maintain ...
Senior Program Manager
Redwood City, CA ยท On-site
$142K - $142K/yr
Work closely with CDx Leads and other clinical development team members to facilitate science-based CDx decision making and drive the execution of the CDx development strategy. * Develop and maintain ...
Cdx information
What is the difference between Cdx vs Data Analyst?
| Aspect | Cdx | Data Analyst |
|---|---|---|
| Required Credentials | Certification in CDX software, technical skills | Bachelor's in Data Science, Statistics, or related field |
| Work Environment | Construction, engineering, or infrastructure projects | Business, finance, healthcare, or marketing sectors |
| Employer & Industry Usage | Used by construction firms, engineering companies | Used across various industries for data interpretation |
| Common Search & Comparison | Yes | Yes |
The main difference between Cdx and Data Analyst lies in their focus and industry application. Cdx specializes in construction and engineering data management, requiring specific certifications and software skills. Data Analysts work across multiple industries analyzing data to inform business decisions, often with a broader educational background. Both roles involve data handling but serve different sectors and purposes.
How does a Clinical Data Exchange (CDX) specialist typically collaborate with other healthcare professionals and IT teams?
What are CDX professionals and what do they do?
What are the key skills and qualifications needed to thrive as a CDX (Clinical Documentation Expert), and why are they important?
Other
Posted 6 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