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Director Ivd Product Development Jobs (NOW HIRING)

CorDx

Regulatory & Compliance Specialist

San Diego, CA

$90K - $95K/yr

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and ...

CorDx

Regulatory & Compliance Specialist

San Diego, CA · On-site

$90K - $95K/yr

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and ...

CorDx

Regulatory & Compliance Specialist

San Diego, CA · On-site

$90K - $95K/yr

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and ...

Predicine, Inc.

Head of Manufacturing

Hayward, CA · On-site

$180 - $240/hr

... , QA/RA, and supply chain teams. Key Responsibilities: Manufacturing Leadership & Strategy * Develop and execute manufacturing strategies that support the growth of the IVD/NGS product portfolio.

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Director Ivd Product Development information

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$73K

$163.7K

$244.5K

How much do director ivd product development jobs pay per year?

As of Aug 8, 2026, the average yearly pay for director ivd product development in the United States is $163,684.00, according to ZipRecruiter salary data. Most workers in this role earn between $131,500.00 and $185,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a director IVD product development?

To thrive as a Director of IVD Product Development, you need deep expertise in in vitro diagnostics, product lifecycle management, and regulatory requirements, usually supported by an advanced degree in a scientific or engineering field. Familiarity with product development tools, quality management systems (such as ISO 13485), and regulatory submission platforms (like FDA or CE Mark processes) is essential. Strong leadership, strategic thinking, and cross-functional communication skills help drive innovation and align multidisciplinary teams. These skills ensure the successful development and launch of compliant, high-quality diagnostic products that meet market and regulatory demands.

What are some common challenges faced by a director IVD product development and how can they be addressed?

A Director of IVD Product Development often encounters challenges such as navigating complex regulatory requirements, aligning cross-functional teams, and managing tight project timelines. Successfully addressing these challenges requires staying up-to-date with evolving regulations (e.g., FDA, CE marking), fostering clear communication among R&D, regulatory, and marketing teams, and implementing robust project management practices. Building strong relationships with stakeholders and encouraging a culture of transparency can help to anticipate risks early and keep product development on track.

What is the difference between Director Ivd Product Development vs Product Manager Ivd?

AspectDirector Ivd Product DevelopmentProduct Manager Ivd
ResponsibilitiesOversees entire product development teams, strategic planning, and long-term product visionManages specific product features, coordinates cross-functional teams, and executes product plans
Required CredentialsTypically requires advanced degrees and extensive industry experienceOften requires a bachelor's or master's degree with relevant experience
Work EnvironmentLeadership role within R&D or product development departments in medical device companiesCollaborates across engineering, marketing, and regulatory teams in similar settings

The main difference is that the Director Ivd Product Development focuses on strategic leadership and overseeing the entire product development process, while the Product Manager Ivd handles day-to-day product planning and execution. Both roles require industry-specific knowledge and collaboration across teams, but the director has a broader scope and higher level of responsibility.

What does a director IVD product development do?

A Director of IVD (In Vitro Diagnostics) Product Development leads teams responsible for creating and improving diagnostic devices and assays used in laboratory testing of biological samples. They oversee the entire product development process, from concept through design, testing, regulatory approval, and market launch. Their role involves strategic planning, cross-functional collaboration, ensuring compliance with regulatory standards, and managing timelines and budgets. Directors in this field play a critical role in bringing innovative diagnostic products to market that improve patient care.
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Director Ivd Product Development jobs near you
Infographic showing various Director Ivd Product Development job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $163,684 per year, or $78.7 per hour.

Senior Director, Clinical Development

DELFI Diagnostics, Inc.

Palo Alto, CA • On-site, Remote

Full-time

Medical, Dental, Vision, Retirement

Re-posted just now

Job description

About Us
 
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.
 
DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto, CA 
About this Role
The Sr. Director, Clinical Development provides leadership across DELFI's clinical study portfolio, working closely with senior leadership and cross-functional teams including R&D, medical, quality, and regulatory. This leader helps to direct the comprehensive strategy for all DELFI clinical studies and to execute on our key trials supporting product development, launch, and reimbursement. We seek an adaptable, rigorous, and collaborative leader who is solidly grounded in clinical development. The role requires technical expertise in clinical study development and operations, oncology, and preferably diagnostics product development.
What You'll Do

Clinical Study Development & Operations

  • Develop and execute clinical studies that generate robust evidence for DELFI's current and future pipeline of product claims, including studies that establish clinical validity and clinical utility.

  • Advance DELFI's development of diagnostic products for cancer, with the detection of lung cancer in USPSTF-eligible individuals as the first indication.

  • Play a key role in implementing the five-year clinical development strategy based on the latest clinical science, evidence gaps, and unmet needs in cancer diagnostics.

  • Partner with R&D Biostatistics to design case-control and prospective clinical studies, and to analyze those studies in accordance with statistical analysis plans and study protocols.

  • Manage the clinical development & clinical operations groups and affiliated CROs and investigators, including vendor selection/management/monitoring, site selection, patient enrollment and follow-up.

  • Develop and manage clinical trial timelines, budget, and risks in accordance with overall product development processes and plans.

Regulatory & Evidence Management

  • Interact with FDA on submissions for IVD product approval, including face-to-face/virtual meetings and written presubmissions in coordination with Regulatory Affairs.

  • Author relevant sections of IVD documents pertaining to clinical development activities, design controls, requirements, etc.

  • Work closely with Medical Affairs to identify evidence gaps and generate real-world data for DELFI's product(s).

  • Collaborate with Data Engineering to store, curate, and cross-reference DELFI's clinical data.

Communication, Thought Leadership & Outreach

  • Participate in industry stakeholder groups and consortia such as BLOODPAC or the Global Alliance for Genomics and Health.

  • Present to senior leadership, company-wide, and at key national scientific and clinical meetings.

What You'll Bring

Required

  • PhD in the physical or natural sciences, or MD. Disciplinary expertise in cancer biology strongly preferred.

  • 8+ years' expertise leading the design & development of clinical studies for either pharmaceutical or diagnostics development, as evidenced by a strong publication record or successful product releases.

  • 3-5 years' experience in IVD diagnostics development.

  • Knowledge of relevant clinical & regulatory standards such as ICH E6(R3) GCP, ISO 14155, ISO 13485, 21 CFR Part 820.

  • 6-8 years' management experience including best practices in recruiting, coaching, performance management, and career development.

  • Excellent 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.

Preferred

  • Familiarity with cutting-edge AI approaches in clinical trials (NLP or LLM for EHRs, digital twins, digital pathology) as well as international data standards such as FAIR principles, FHIR-OMOP, or Common Data Models.

$260,000 - $320,000 a year
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.
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