ZipRecruiter

Log In

1

Director Assay Development Jobs (NOW HIRING)

GENERAL FLUIDICS CORPORATION

Be Seen First

Director of Assay Development

Watertown, MA · On-site

... 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 ...

next page

Showing results 1-20

People also search for

All JobsDirector Assay Development Jobs

Director Assay Development information

See salary details

$21K

$93.3K

$180K

How much do director assay development jobs pay per year?

As of May 30, 2026, the average yearly pay for director assay development in the United States is $93,350.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,500.00 and $103,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director of Assay Development, and why are they important?

To thrive as a Director of Assay Development, you need a strong background in molecular biology, biochemistry, or a related field, often supported by an advanced degree (PhD or MS) and extensive experience in assay design and validation. Familiarity with laboratory automation, data analysis software, and regulatory standards such as CLIA or GLP is typically required. Leadership, project management, and effective communication are essential soft skills for guiding teams and collaborating across departments. These competencies are crucial for ensuring robust assay performance, meeting regulatory requirements, and driving innovation within the organization.

What are the primary challenges faced by a Director of Assay Development when leading cross-functional teams?

A Director of Assay Development often manages multidisciplinary teams including scientists, engineers, and regulatory specialists. One of the main challenges is ensuring clear communication and alignment among team members with diverse expertise and priorities, especially when balancing scientific innovation with regulatory compliance and project timelines. Additionally, adapting to evolving technologies and customer requirements while maintaining assay robustness and reproducibility can be demanding. Effective leadership in this role requires fostering collaboration, efficiently resolving conflicts, and strategically prioritizing resources to meet both short-term milestones and long-term organizational goals.

What does a Director of Assay Development do?

A Director of Assay Development leads teams responsible for designing, developing, and validating laboratory assays, which are tests used to detect or measure specific biological molecules. They oversee project timelines, ensure regulatory compliance, manage budgets, and collaborate with research, clinical, and commercial teams. This role often involves strategic planning, troubleshooting technical challenges, and ensuring that assay products meet quality and performance standards necessary for clinical or research applications.

What is the difference between Director Assay Development vs Senior Assay Scientist?

AspectDirector Assay DevelopmentSenior Assay Scientist
CredentialsAdvanced degree (PhD or MS), leadership experienceMaster's or PhD, specialized technical expertise
Work EnvironmentLeadership, project management, cross-functional teamsLaboratory research, assay development, experimental work
Employer & IndustryBiotech, pharma, diagnostics companiesResearch labs, biotech firms, pharmaceutical companies
Search & Comparison IntentUnderstanding leadership roles in assay developmentTechnical assay development and research roles

The main difference between a Director Assay Development and a Senior Assay Scientist lies in their responsibilities and experience. The Director oversees project strategy, manages teams, and interacts with upper management, while the Senior Assay Scientist focuses on hands-on assay development and technical research. Both roles require strong scientific credentials, but the director position emphasizes leadership and strategic planning.

More about Director Assay Development jobs
What cities are hiring for Director Assay Development jobs? Cities with the most Director Assay Development job openings:
What are the most commonly searched types of Assay Development jobs? The most popular types of Assay Development jobs are:
What states have the most Director Assay Development jobs? States with the most job openings for Director Assay Development jobs include:
What job categories do people searching Director Assay Development jobs look for? The top searched job categories for Director Assay Development jobs are:
Director Assay Development jobs near you
Senior Director, Assay Development

Senior Director, Assay Development

DELFI Diagnostics, Inc.

Palo Alto, CA

Full-time

Posted 17 days ago

Job description

 

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.

In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

  • Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.

  • Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class 

  • Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

About the role

As Senior Director of Assay Development, you will own all development activities across DELFI’s NGS-based cancer screening portfolio — driving the transition of innovative assays into verified, validated, and manufacturable IVD products. Reporting to the CTO, you will lead a team of scientists and functional leaders and serve as a key voice on product strategy across R&D, Quality, Regulatory, and Manufacturing.

This role demands hands-on scientific judgment to know when and where to take calculated risks — and when not to — leading with science while anchoring every decision in pragmatism to keep programs moving against ambitious timelines without compromising quality or integrity.

What you'll do

  • Own end-to-end assay development strategy across all LDT and IVD programs — from study design and execution through protocol approval, analytical validation, regulatory documentation, and FDA PMA submissions

  • Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards (21 CFR Part 820, ISO 13485, ISO 14971, IVDR)

  • Contribute to and/or lead Formal Design Reviews at key milestones; partner with Systems Engineering to ensure product requirements are fully addressed through design verification

  • Oversee reagent development and qualification, automated process scale-up, and statistical process control (SPC) for lab production environments

  • Lead design transfer activities across programs, ensuring robust handoffs to manufacturing and sustained assay performance at commercial scale

  • Report directly to the CTO; lead a team of scientists and functional leaders across assay development, validation, and manufacturing readiness

  • Design and own the operational infrastructure for the function — scalable processes, SOPs, design control frameworks, and traceability systems aligned to 21 CFR Part 820 and ISO 13485

  • Apply hands-on scientific judgment to make deliberate risk decisions — knowing where to push for speed and where standards are non-negotiable — keeping programs moving against ambitious timelines without compromising quality or integrity

  • Represent Assay Development at the executive level; align with the CTO, VP of Regulatory & Quality, and other senior leaders on portfolio priorities and product strategy

What you'll bring

Required

  • PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline

  • 12+ years in IVD and/or LDT assay development in regulated environments

  • Hands-on expertise in AV and design verification of multi-marker genomic or ‘omic-based assays, with direct experience contributing to FDA regulatory submissions

  • Deep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR

  • Proven track record designing scalable processes, SOPs, quality systems, and operational infrastructure in regulated IVD environments

  • Demonstrated ownership of late-stage development programs through design transfer and manufacturing scale-up

  • Ability to lead with science while anchoring in pragmatism — applying hands-on expertise to make sound risk judgments that keep programs on ambitious timelines without sacrificing rigor or compliance

  • 8+ years’ management experience including best practices in recruiting, coaching, performance management, and career development

  • Superb communication skills including mastery in written & oral presentations, large- and small-group forums

  • Start-up mindset: passionate, innovative, accountable, able to rapidly prioritize and triage, biased to action

  • Proactive, decisive, and composed with a balance of high IQ & EQ

Preffered 

    • Direct leadership of FDA PMA submissions

    • Background in reagent development, critical reagent qualification, and SPC in manufacturing environments

    • Experience in high-growth or scaling biotech/diagnostics companies; track record of multiple launched LDT/IVD products

Actual base pay will consider experience, skillset, education, and geography.
 
This role may be eligible for other forms of compensation, including an annual bonus and a new hire equity grant, subject to the terms of the applicable plans and Company discretion. All employees are also eligible for DELFI's comprehensive and competitive benefits package, including but not limited to: a flexible time-off policy; a 401(k) retirement plan; an extremely competitive medical, dental, and vision coverage; onsite lunch 3 days a week; and other wellness related offerings.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.