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Clinical Assay Development Jobs (NOW HIRING)

Develop new molecular assays for pre-clinical decision making, defining mechanisms of action in ... Develop and review Feasibility and later Development Phase Plans and Reports with CSO, performing ...

$260K - $305K/yr

Directly manage the clinical assay leadership function and ensure clinical assay strategy is ... Oversee translational development strategies, including mechanism-of-action studies ...

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Clinical Assay Development information

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$36K

$94.3K

$143.5K

How much do clinical assay development jobs pay per year?

As of Sep 10, 2026, the average yearly pay for clinical assay development in the United States is $94,314.00, according to ZipRecruiter salary data. Most workers in this role earn between $62,500.00 and $128,000.00 per year, depending on experience, location, and employer.

What is clinical assay development?

Clinical assay development is the process of designing, validating, and implementing laboratory tests that measure specific biomarkers or analytes in clinical samples, such as blood or tissue. These assays are crucial for diagnosing diseases, monitoring patient progress, and supporting clinical trials for new drugs or therapies. Professionals in this field work to ensure that assays are accurate, reliable, and compliant with regulatory standards. The process often involves collaboration between scientists, clinicians, and regulatory experts to bring new diagnostic tools from concept to clinical use.

What are the key skills and qualifications needed to thrive in clinical assay development?

To thrive in Clinical Assay Development, you need a solid background in molecular biology, biochemistry, or related life sciences, often supported by an advanced degree and laboratory experience. Familiarity with laboratory automation, statistical analysis software, and regulatory standards such as GLP or CLIA is typically required. Attention to detail, problem-solving abilities, and strong collaboration skills are crucial soft skills for this role. These competencies ensure accurate assay design, reliable data generation, and compliance with industry standards for successful clinical outcomes.

What are some common challenges faced by professionals in clinical assay development, and how can they be addressed?

Professionals in Clinical Assay Development often encounter challenges such as ensuring assay reproducibility, managing strict regulatory requirements, and troubleshooting unexpected results. Effective communication with cross-functional teams—including research scientists, quality assurance, and regulatory affairs—is essential to quickly resolve issues and maintain project timelines. Staying current with evolving industry standards and investing in ongoing training can help overcome these hurdles and ensure the success of assay development projects.

What is the difference between Clinical Assay Development vs Laboratory Technician?

AspectClinical Assay DevelopmentLaboratory Technician
CredentialsBachelor's or higher in life sciences, specialized training in assay developmentAssociate's degree or certification in laboratory techniques
Work EnvironmentResearch labs, biotech companies, pharmaceutical firmsHospital labs, research facilities, diagnostic labs
Job FocusDesigning, optimizing, and validating assays for clinical usePerforming routine lab tests and sample processing

Clinical Assay Development involves creating and validating diagnostic tests, requiring specialized knowledge and advanced credentials. Laboratory Technicians focus on executing established tests and sample handling. While both roles work in laboratory settings, their responsibilities and expertise levels differ significantly.

What are popular job titles related to Clinical Assay Development jobs?

For Clinical Assay Development jobs, the most frequently searched job titles are:

Infographic showing various Clinical Assay Development job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 82% Full Time, 14% Part Time, and 2% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $94,314 per year, or $45.3 per hour.

Director of Assay Development

Watertown, MA • On-site

GENERAL FLUIDICS CORPORATION
Medical Equipment and Supplies Manufacturing • 11 - 50 employees

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 21 days ago


Job description

General Fluidics is a clinical diagnostics company developing a novel point-of-care platform capable of simultaneously measuring clinical chemistry, hematology, and immunoassays from human and animal blood samples (https://www.generalfluidics.com).


We are seeking a highly creative and broadly skilled Associate Director or Director, Assay Development to help expand our growing menu of diagnostic assays across veterinary medicine and the in vitro diagnostics (IVD) market. This individual will play a key leadership role in the development, optimization, and validation of assays powering our next-generation diagnostic platform.


This is an opportunity to contribute directly to the advancement of innovative diagnostic technology within a highly collaborative and fast-moving biotech environment.


Essential Duties and Responsibilities

  • Design, develop, and validate new clinical chemistry, hematology, and immunoassays on our point-of-care diagnostic platform using human and animal specimens.
  • Partner closely with design/manufacturing engineers, suppliers, and commercial partners to optimize consumables, hardware, software, and overall system performance.
  • Support expansion into new clinical applications, specimen types, and testing formats.
  • Design and execute laboratory experiments to optimize assay and instrument performance in a hands-on, collaborative environment.
  • Analyze assay and instrument performance data to support analytical validation, regulatory clearance, and commercial launch activities.
  • Support and manage clinical studies, external collaborations, and commercial partnership initiatives.
  • Author experimental protocols, standard operating procedures (SOPs), technical reports, and validation documentation.
  • Maintain laboratory quality assurance practices including controls, calibration, and proficiency testing.
  • Ensure laboratory operations comply with applicable safety, health, and environmental regulations.
  • Work safely with both human and veterinary specimens in accordance with laboratory safety standards and procedures.


Qualifications and Experience

  • MS or PhD in biotechnology, biology, chemistry, biomedical engineering, clinical laboratory science, or a related scientific discipline.
  • 3–5+ years of experience in industrial, hospital, veterinary, or academic laboratory environments.
  • Experience supporting product development within clinical diagnostics, including assay development, analytical validation, manufacturing support, or regulatory activities.
  • Strong experimental design, laboratory troubleshooting, and scientific data analysis skills.
  • Experience working at the intersection of engineering, automation, and wet chemistry preferred.
  • Hands-on experience with clinical instrumentation such as flow cytometry, hematology systems, clinical chemistry analyzers, and/or immunoassay platforms.
  • Familiarity with laboratory quality systems and regulated laboratory environments (e.g., BSL-2, GLP, CLIA, CAP) strongly preferred. Veterinary diagnostics experience is a plus.
  • Strong written and verbal communication skills with the ability to clearly communicate scientific concepts, experimental findings, and technical data.
  • Ability to thrive in a fast-paced, collaborative biotech startup environment with a high degree of ownership and initiative.


Why Join General Fluidics

  • Work on breakthrough point-of-care diagnostic technology
  • High-impact role within a growing biotech company
  • Collaborative and innovative R&D environment
  • Opportunity to help shape next-generation diagnostic products


Benefits

  • 401(k)
  • Health insurance
  • Dental / Vision insurance
  • Disability insurance
  • Paid time off
  • Annual bonus program

Company Description

General Fluidics, is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology and immunoassays from human and animal blood (https://www.generalfluidics.com). We are creating an entirely new category of blood testing technology that brings the quality and menu of the reference laboratory to the point of care. Our AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus.