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.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.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.

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.

Waters Biosciences is a world leader in providing innovative flow cytometry diagnostic and research tools to laboratory professionals, clinicians, and clinical/life science researchersThe 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.

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 SystemEnsure 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.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 SystemEnsure 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.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 SystemEnsure 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.

• Serve as the technical and scientific authority for clinical flow cytometry assay and CDx development, providing guidance from feasibility through commercialization.

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.

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.

Advise on all matters related to clinical flow cytometry assay development.

• Assess technical feasibility of projects, identify risks, propose solutions.

Assess technical feasibility of projects, identify risks, propose solutions.

• Ensure scientific rigor for all technical and design reviews.

Ensure scientific rigor for all technical and design reviews.

• Ensure compliance with Water’s Biosciences Phase Gated Product Development System

Ensure compliance with Water’s Biosciences Phase Gated Product Development System

• Ensure R&D activities satisfy regulatory standards including documentation and reporting requirements.

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.

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.

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.

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 at conferences and scientific meetings.

• Represent Waters Biosciences externally with regulatory agencies, notified bodies, FDA, etc.

Represent Waters Biosciences externally with regulatory agencies, notified bodies, FDA, etc.

• Ensure customer perspectives are incorporated into all aspects of product development.

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.

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.

Identify promising new clinically relevant technologies and/or assays.

• Contribute to business and portfolio strategy, supporting decisions on investment, prioritization, and external engagement.

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.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.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.

• Advanced Degree (Masters or MD/PhD) in a relevant scientific field is required.

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.

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 flow cytometry application and data analysis experience.

• Extensive clinical diagnostic R&D experience in an industry setting.

Extensive clinical diagnostic R&D experience in an industry setting.

• Demonstrated analytical and technical problem solving skills.

Demonstrated analytical and technical problem solving skills.

• Demonstrated ability to effectively work in a team environment.

Demonstrated ability to effectively work in a team environment.

• Experience working across geographies in different countries and time zones.

Experience working across geographies in different countries and time zones.

• Excellent verbal, written and presentation skills required.

Excellent verbal, written and presentation skills required.

• Experience working with regulatory bodies.

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.

Understanding of regulations, standards and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, CE-IVD, ISO 13485, etc.