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Cdx Jobs (NOW HIRING)

Precision for Medicine

Director, CDx Regulatory Consultant

$153K - $202K/yr

The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing ...

BeiGene, Inc.

Director CDx Development

$176K - $236K/yr

The Companion Diagnostics (CDx) Lead will be responsible for defining and executing end-to-end diagnostic strategies that are fully aligned with clinical development programs and timelines. This role ...

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Cdx information

What is the difference between Cdx vs Data Analyst?

AspectCdxData Analyst
Required CredentialsCertification in CDX software, technical skillsBachelor's in Data Science, Statistics, or related field
Work EnvironmentConstruction, engineering, or infrastructure projectsBusiness, finance, healthcare, or marketing sectors
Employer & Industry UsageUsed by construction firms, engineering companiesUsed across various industries for data interpretation
Common Search & ComparisonYesYes

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?

A Clinical Data Exchange (CDX) specialist works closely with healthcare providers, IT staff, and data analysts to ensure secure and efficient transfer of patient information between different electronic health record (EHR) systems. Collaboration often involves participating in cross-functional meetings to address data integration challenges, clarify technical requirements, and troubleshoot interoperability issues. CDX specialists also provide training or support to end-users and help maintain compliance with healthcare data privacy regulations. This teamwork is essential to ensure that patient information flows seamlessly and securely across various healthcare platforms.

What are CDX professionals and what do they do?

CDX typically stands for 'Clinical Data Exchange' professionals. These individuals are responsible for managing, integrating, and facilitating the secure sharing of clinical data between healthcare organizations, providers, and systems. Their work ensures that patient data is accessible, accurate, and compliant with healthcare regulations such as HIPAA. CDX professionals often work with electronic health records (EHRs), interoperability standards, and data security protocols to improve patient care and operational efficiency.

What are the key skills and qualifications needed to thrive as a CDX (Clinical Documentation Expert), and why are they important?

To thrive as a Clinical Documentation Expert (CDX), you need a solid background in medical terminology, clinical coding, and healthcare documentation, often supported by credentials such as RHIA, RHIT, or CCDS. Familiarity with electronic health record (EHR) systems, clinical coding software, and regulatory compliance tools is typically required. Strong attention to detail, critical thinking, and effective communication skills help ensure accurate and thorough documentation. These skills are crucial for maintaining healthcare quality, supporting reimbursement, and ensuring regulatory compliance.
More about Cdx jobs
What states have the most Cdx jobs? States with the most job openings for Cdx jobs include:
What job categories do people searching Cdx jobs look for? The top searched job categories for Cdx jobs are:
Cdx jobs near you
Infographic showing various Cdx job openings in the United States as of July 2026, with employment types broken down into 97% Full Time, and 3% Contract. Highlights an 79% Physical, 5% Hybrid, and 16% Remote job distribution.
Director, CDx Regulatory Consultant

Director, CDx Regulatory Consultant

Precision for Medicine

Remote

$153K - $202K/yr

Full-time

Medical, Life, Retirement, PTO

Posted 15 days ago

Job description

Position Summary
The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. This role will translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.
Essential functions of the job include but are not limited to
Consulting Services
  • Serve as the CDx regulatory subject matter expert for strategic positioning of client programs inclusive of CDx, including relevant FDA precedents, EU IVDR considerations, global submission expectations, and diagnostic commercialization pathways.
  • Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives.
  • Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives.
  • Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.
  • Develop integrated Rx Dx regulatory strategies that align diagnostic development, biomarker strategy, clinical trial enrollment, therapeutic development milestones, and commercialization objectives for pharmaceutical, biotechnology, and diagnostic clients.
  • Advise clients on regulatory requirements for use of assays in clinical trials, including patient selection, inclusion or exclusion testing, significant risk and nonsignificant risk determinations, IRB considerations, investigational device requirements, and global performance study obligations.
  • Direct the preparation of global regulatory submissions and supporting documentation for companion diagnostics and clinical trial assays, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, EU IVDR Annex XIV performance study applications, technical documentation, and other country-specific submissions.
  • Lead interactions with regulatory authorities and notified bodies, including preparation for FDA meetings, interpretation of agency feedback, development of response strategies, meeting minutes, and follow-up communications on behalf of clients.
  • Review and direct the development of analytical validation plans, clinical performance study plans, diagnostic clinical protocols, statistical analysis synopses, technical reports, intended use statements, labeling, and other submission-ready documents for CDx programs.
  • Apply IVD quality system, design control, risk management, and post-market regulatory expertise to support CDx readiness from early development through approval, launch, and lifecycle management.
  • Stay current on CDx regulatory, scientific, and market developments, including FDA guidance, EU IVDR implementation, notified body expectations, global regulatory trends, diagnostic precedents, and evolving precision medicine requirements.

Business Development
  • Generate new CDx regulatory consulting opportunities through established relationships with pharmaceutical, biotechnology, diagnostic, laboratory, and precision medicine stakeholders.
  • Partner with the business development team to evaluate CDx and clinical trial assay requests for proposals, identify regulatory assumptions, assess key risks, and define submission strategies and approval timelines.
  • Support bid defense meetings by clearly communicating the CDx regulatory pathway, clinical trial assay considerations, submission risks, agency interaction strategy, and value proposition to prospective clients.
  • Advise on work orders, change orders, master service agreements, and other contract documents to ensure CDx regulatory scope, deliverables, assumptions, and client responsibilities are clearly defined.
  • Lead client workshops, scientific conference sessions, and educational presentations focused on CDx development, Rx Dx co-development, clinical trial assay strategy, and global IVD regulatory requirements.

Administrative
  • Ensure the quality, consistency, and regulatory accuracy of all CDx strategy documents, client deliverables, submissions, meeting materials, and other consulting work products in accordance with corporate standards.
  • Time entry and following SOPs
  • Manage, mentor, motivate, and develop regulatory consulting staff to support a scalable CDx and IVD regulatory consulting practice.
  • Support and contribute to a collaborative, client-focused consulting culture that advances Precision for Medicine`s CDx, IVD, and precision medicine regulatory capabilities.
Qualifications
Minimum Required:
  • Bachelor`s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent relevant experience may be considered.
  • Minimum 5 years of applicable consulting experience with a primary focus in IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs.

Other required:
  • Minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment.
  • Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.
  • Strong written and verbal communication skills, with demonstrated ability to translate complex CDx regulatory requirements into clear, practical recommendations for clients and cross-functional teams.
  • Strong scientific and analytical skills, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information in support of CDx regulatory strategy.
  • Ability to solve complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions.
  • Strong leadership, team building, and interpersonal skills, including the ability to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, quality, clinical, laboratory, and commercial functions.

Preferred:
Master`s degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or a related discipline.
RAC certification
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$162,000- $243,000 USD
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

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