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How much do companion diagnostics jobs pay per hour?

As of Aug 3, 2026, the average hourly pay for companion diagnostics in the United States is $15.05, according to ZipRecruiter salary data. Most workers in this role earn between $13.94 and $15.62 per hour, depending on experience, location, and employer.

What are companion diagnostics?

Companion diagnostics are laboratory tests or devices that provide information essential for the safe and effective use of a corresponding drug or biological product. They help determine whether a patient is likely to benefit from a particular therapy or if they may be at increased risk for serious side effects. These diagnostics are often used in personalized medicine, especially in cancer treatment, to tailor therapies to individual patients based on their genetic makeup or specific biomarkers.

How does a professional in Companion Diagnostics typically collaborate with pharmaceutical and clinical teams during the drug development process?

Professionals in Companion Diagnostics work closely with pharmaceutical researchers and clinical trial teams to co-develop diagnostic tests that help identify patients most likely to benefit from specific therapies. This collaboration involves regular meetings to align on biomarker strategies, sharing clinical trial data, and ensuring that diagnostic assays meet regulatory requirements in tandem with the drug. It also includes troubleshooting assay performance and adapting protocols based on patient responses and trial outcomes. Effective communication and project management skills are essential, as timelines are often tight and priorities may shift quickly.

What are the key skills and qualifications needed to thrive as a Companion Diagnostics Specialist, and why are they important?

To thrive as a Companion Diagnostics Specialist, you generally need a background in life sciences, molecular biology, or biomedical engineering, often supported by a relevant degree and experience in clinical diagnostics. Familiarity with laboratory technologies such as PCR, NGS platforms, and regulatory standards (e.g., FDA, CLIA) is typically required, and certifications in molecular diagnostics are advantageous. Strong analytical thinking, attention to detail, and effective communication with cross-functional teams make someone stand out in this role. These skills ensure accurate test development, regulatory compliance, and successful collaboration between diagnostic and therapeutic development teams, which are critical for patient-specific treatment strategies.

What is the difference between Companion Diagnostics vs Laboratory Technician?

AspectCompanion DiagnosticsLaboratory Technician
Required CredentialsTypically requires a degree in medical laboratory science, biology, or related field; certifications like ASCP are commonAssociate's or bachelor's degree in laboratory science or related field; certification may be required
Work EnvironmentPharmaceutical or biotech labs, hospitals, research facilitiesHospitals, diagnostic labs, research institutions
Industry UsageUsed in personalized medicine to guide treatment decisionsPerforms routine lab tests and sample processing

Companion Diagnostics specialists focus on developing tests that help tailor treatments to patients, requiring specialized knowledge and certifications. Laboratory Technicians perform routine lab work and support diagnostic processes. While both roles work in laboratory settings, their responsibilities and expertise levels differ significantly.

More about Companion Diagnostics jobs
What cities are hiring for Companion Diagnostics jobs? Cities with the most Companion Diagnostics job openings:
What states have the most Companion Diagnostics jobs? States with the most job openings for Companion Diagnostics jobs include:
What job categories do people searching Companion Diagnostics jobs look for? The top searched job categories for Companion Diagnostics jobs are:
Companion Diagnostics jobs near you
Infographic showing various Companion Diagnostics job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 44% Full Time, 54% Part Time, and 1% Contract. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $31,304 per year, or $15.1 per hour.

Director, Regulatory Affairs Companion Diagnostics (CDx)

Revolution Medicines

Redwood City, CA • Hybrid

$183K - $242K/yr

Other

Posted 12 days ago

Job description

The Opportunity:

The Director, Regulatory Affairs Companion Diagnostics is accountable for developing and executing global regulatory strategies for companion diagnostics supporting Revolution Medicines' precision oncology portfolio. This individual will serve as the regulatory lead for companion diagnostic development programs, partnering closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Science, Commercial, and external diagnostic partners to ensure successful co-development and global registration of therapeutic products and associated companion diagnostics.

The Director will provide strategic regulatory leadership across all phases of companion diagnostic development, ensuring alignment between drug and diagnostic regulatory strategies, timelines, and submissions. This individual must possess a strong understanding of global in vitro diagnostic (IVD) regulations, companion diagnostic development, oncology drug development, and evolving global regulatory expectations. The successful candidate will be a collaborative leader with demonstrated experience managing complex cross-functional programs and interactions with health authorities and diagnostic partners.

  • Develop and execute global regulatory strategies for companion diagnostics supporting oncology drug development programs from early development through commercialization.

  • Serve as the Regulatory Lead for companion diagnostic programs, ensuring coordinated regulatory strategies between therapeutic and diagnostic products.

  • Provide strategic regulatory guidance for companion diagnostic development plans, analytical and clinical validation, bridging strategies, labeling, and lifecycle management.

  • Participate in regulatory interactions with FDA (CDRH and CDER), EMA, PMDA, and other global health authorities regarding companion diagnostic development and registration.

  • Partner closely with external diagnostic manufacturers to support successful co-development, regulatory submissions, inspections, and post-approval activities.

  • Ensure regulatory alignment between therapeutic and diagnostic submission timelines.

  • Provide regulatory leadership for biomarker and precision medicine strategies supporting patient selection and clinical trial enrollment.

  • Interpret evolving global regulations, guidance documents, and industry trends related to companion diagnostics and precision medicine, incorporating them into development strategies.

  • Represent Companion Diagnostics Regulatory Affairs on cross-functional development teams and to senior leadership.

  • Drive regulatory risk assessment and mitigation strategies to support development milestones and product approvals.

  • Develop and maintain strong collaborative relationships across Regulatory Science, Clinical Development, Translational Medicine, Commercial, and external partners.

  • Support development of regulatory policies, procedures, and best practices for companion diagnostics across the organization.

Required Skills, Experience and Education:

  • Advanced degree or bachelor's degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline with a minimum of 12+ years of pharmaceutical, biotechnology, diagnostics, or combination product experience, including at least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics.

  • Demonstrated experience developing and executing global regulatory strategies for companion diagnostics supporting oncology or precision medicine programs.

  • Deep knowledge of FDA companion diagnostic guidance, PMA requirements, IDE regulations, IVDR, and global IVD regulatory frameworks.

  • Experience leading regulatory interactions with FDA CDRH and CDER, EMA, PMDA, and other international health authorities.

  • Demonstrated success managing regulatory aspects of drug-diagnostic co-development programs through product approval.

  • Experience working with external diagnostic partners.

  • Strong understanding of biomarker development, assay validation, analytical performance studies, clinical performance studies, and companion diagnostic lifecycle management.

  • Proven ability to influence cross-functional teams and integrate regulatory strategy across drug and diagnostic development organizations.

  • Excellent communication, leadership, negotiation, planning, and organizational skills with the ability to manage multiple complex programs simultaneously.

  • Experience representing Regulatory Affairs to senior leadership and executive governance committees.

Preferred Skills:

  • Advanced degree (PhD, PharmD, MD, MS, or equivalent) is preferred.

  • Experience supporting global oncology registration programs involving companion diagnostics.

  • Working knowledge of EU IVDR implementation and international companion diagnostic regulations.

  • Experience supporting next-generation sequencing (NGS), PCR-based, or multiplex molecular diagnostics. 

    #LI-Hybrid #LI-JC1

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