Director R&D – Clinical Assay/CDx Development

Overview

Waters Biosciences is a world leader in providing innovative flow cytometry diagnostic and research tools to laboratory professionals, clinicians, and clinical/life science researchers The Director of R&D – Clinical Assay & CDx Development will serve as a senior technical and scientific leader responsible for advancing flow cytometry–based clinical assays and companion diagnostics (CDx) from early concept through validation and commercialization.

 

This role is ideal for an individual with deep, hands‑on experience in clinical assay development within a regulated IVD environment, who can provide leadership across assay design, analytical validation, regulatory strategy, and cross‑functional execution. The Director will play a critical role in ensuring scientific rigor, regulatory compliance, and clinical relevance while shaping the long‑term diagnostic innovation strategy for Waters Biosciences.

Responsibilities

• Serve as the technical and scientific authority for clinical flow cytometry assay and CDx development, providing guidance from feasibility through commercialization.
• Lead and advise on assay design, optimization, analytical performance characterization, verification, and validation, ensuring fitness for intended clinical use.
• Advise on all matters related to clinical flow cytometry assay development.
• Assess technical feasibility of projects, identify risks, propose solutions.
• Ensure scientific rigor for all technical and design reviews.
• Ensure compliance with Water’s Biosciences Phase Gated Product Development System
• Ensure R&D activities satisfy regulatory standards including documentation and reporting requirements.
• Effectively collaborate and communicate across all functions ensuring awareness and understanding of, and agreement to the execution strategy/plans.
• Grow the technical capabilities of the team by demonstrating best practices, facilitating training sessions and/or mentoring junior associates.
• Provide succinct program updates to the program manager or other business leads as required.
• Represent Waters Biosciences externally at conferences and scientific meetings.
• Represent Waters Biosciences externally with regulatory agencies, notified bodies, FDA, etc.
• Ensure customer perspectives are incorporated into all aspects of product development.
• Engage with related industrial and medical institutions to stay updated on emerging trends in the field.
• Identify promising new clinically relevant technologies and/or assays.
• Contribute to business and portfolio strategy, supporting decisions on investment, prioritization, and external engagement.

 

Qualifications

• Advanced Degree (Masters or MD/PhD) in a relevant scientific field is required.
• 10+ years of industry experience developing and commercializing clinical assays, ideally within an IVD or CDx environment.
• Extensive flow cytometry application and data analysis experience.
• Extensive clinical diagnostic R&D experience in an industry setting.
• Demonstrated analytical and technical problem solving skills.
• Demonstrated ability to effectively work in a team environment.
• Experience working across geographies in different countries and time zones.
• Excellent verbal, written and presentation skills required.
• Experience working with regulatory bodies.
• Understanding of regulations, standards and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, CE-IVD, ISO 13485, etc.

Company Description

Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide. 

 

 

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.