Davita Inc.
Director R&D - Clinical Assay/CDx Development
Davita Inc. - San Diego, California, United States, 92189
Work at Davita Inc.
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Overview
Job Description Summary
BD 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
will serve as a key technical leader for new, flow cytometry-based, clinical assay projects, making informed recommendations on all development aspects from concept through to commercialization with a sharp focus on scientific rigor and regulatory compliance. This role is ideal for someone who thrives in environments requiring both deep technical insight and strong leadership/influencing skills. If you are passionate about advancing clinical diagnostics and making a global impact while mentoring a team and shaping future medical technology, this position offers significant growth and innovation opportunities. The role requires advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D. The individual must understand R&D requirements and possess in-depth knowledge of product characterization, verification and validation activities, and the regulatory landscapes that guide these activities. By collaborating across functions including Program Management, Marketing, Regulatory, Quality, and Medical Affairs, this leader will ensure scientific and logistical project alignment. Creating detailed critical path maps and integrated dependency plans will be essential to keep projects on schedule and within budget. Additionally, leveraging continuous improvement skills to streamline development processes in compliance with regulatory guidelines will help accelerate launch timelines. Job Responsibilities: Advise on all matters related to clinical flow cytometry assay development. Assess technical feasibility, identify risks, and propose solutions. Ensure scientific rigor in technical and design reviews. Ensure compliance with BD's Phase Gated Product Development System. Maintain R&D activities in accordance with regulatory standards, including documentation and reporting. Collaborate effectively across functions to ensure alignment on strategies and plans. Develop the technical skills of the team through training and mentoring. Provide concise program updates to management as needed. Represent BD at conferences, scientific meetings, and with regulatory agencies such as FDA. Incorporate customer perspectives into product development. Engage with industrial and medical institutions to stay current on emerging trends. Identify promising new technologies and assays. Contribute to overall business strategy. Minimum Qualifications: Master’s or MD/PhD in a relevant scientific field. At least ten years of experience bringing clinical products to market. Extensive experience in flow cytometry applications and data analysis. Deep clinical diagnostic R&D experience in industry. Strong analytical and problem-solving skills. Ability to work effectively in a team and across geographies. Excellent communication skills. Experience with regulatory bodies and understanding of standards like 21 CFR, CE-IVD, ISO 13485. Why Join Us? At BD, you will be part of a team that values your contributions, encourages growth, and fosters an inclusive culture. You will learn from inspiring leaders, help shape the company’s future, and continually develop your skills through BD University. Join us to make a difference in health technology and leave a meaningful legacy. For more information, visit
https://bd.com/careers .
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Director
will serve as a key technical leader for new, flow cytometry-based, clinical assay projects, making informed recommendations on all development aspects from concept through to commercialization with a sharp focus on scientific rigor and regulatory compliance. This role is ideal for someone who thrives in environments requiring both deep technical insight and strong leadership/influencing skills. If you are passionate about advancing clinical diagnostics and making a global impact while mentoring a team and shaping future medical technology, this position offers significant growth and innovation opportunities. The role requires advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D. The individual must understand R&D requirements and possess in-depth knowledge of product characterization, verification and validation activities, and the regulatory landscapes that guide these activities. By collaborating across functions including Program Management, Marketing, Regulatory, Quality, and Medical Affairs, this leader will ensure scientific and logistical project alignment. Creating detailed critical path maps and integrated dependency plans will be essential to keep projects on schedule and within budget. Additionally, leveraging continuous improvement skills to streamline development processes in compliance with regulatory guidelines will help accelerate launch timelines. Job Responsibilities: Advise on all matters related to clinical flow cytometry assay development. Assess technical feasibility, identify risks, and propose solutions. Ensure scientific rigor in technical and design reviews. Ensure compliance with BD's Phase Gated Product Development System. Maintain R&D activities in accordance with regulatory standards, including documentation and reporting. Collaborate effectively across functions to ensure alignment on strategies and plans. Develop the technical skills of the team through training and mentoring. Provide concise program updates to management as needed. Represent BD at conferences, scientific meetings, and with regulatory agencies such as FDA. Incorporate customer perspectives into product development. Engage with industrial and medical institutions to stay current on emerging trends. Identify promising new technologies and assays. Contribute to overall business strategy. Minimum Qualifications: Master’s or MD/PhD in a relevant scientific field. At least ten years of experience bringing clinical products to market. Extensive experience in flow cytometry applications and data analysis. Deep clinical diagnostic R&D experience in industry. Strong analytical and problem-solving skills. Ability to work effectively in a team and across geographies. Excellent communication skills. Experience with regulatory bodies and understanding of standards like 21 CFR, CE-IVD, ISO 13485. Why Join Us? At BD, you will be part of a team that values your contributions, encourages growth, and fosters an inclusive culture. You will learn from inspiring leaders, help shape the company’s future, and continually develop your skills through BD University. Join us to make a difference in health technology and leave a meaningful legacy. For more information, visit
https://bd.com/careers .
#J-18808-Ljbffr