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.
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