Hispanic Technology Executive Council
Director R&D - Clinical Assay/CDx Development
Hispanic Technology Executive Council, San Diego, California, United States, 92189
Overview
BD Biosciences is a world leader in providing innovative flow cytometry diagnostic and research tools. 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 focus on scientific rigor and regulatory compliance. This role requires advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D, and success across functions including Program Management, Marketing, Regulatory, Quality, and Medical Affairs to align scientific and logistical aspects of projects. By leveraging continuous improvement skills, this individual will identify opportunities to streamline development processes that comply with regulatory guidelines and accelerate launch timelines. The position also involves mentoring a team and representing BD externally at conferences, regulatory agencies, and with customers. Job Responsibilities
Advise on all matters related to clinical flow cytometry assay development. Assess technical feasibility of projects, identify risks, and propose solutions. Ensure scientific rigor for all technical and design reviews. Ensure compliance with BD’s Phase Gated Product Development System. Ensure R&D activities satisfy regulatory standards including documentation and reporting requirements. Collaborate across functions to ensure awareness and adherence to execution strategy and plans. Grow technical capabilities of the team through best practices, training, and mentoring. Provide succinct program updates to the program manager or other business leads as required. Represent BD externally at conferences, scientific meetings, and with regulatory agencies (e.g., FDA, notified bodies). Incorporate customer perspectives into product development and stay updated on emerging trends. Identify promising new clinically relevant technologies and/or assays; contribute to business strategy. Minimum Qualifications including Education and Experience
Advanced Degree (Masters or MD/PhD) in a relevant scientific field is required. Minimum of ten years of experience bringing clinical products to market. 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; ability to work effectively in a team and across geographies/time zones. Excellent verbal, written and presentation skills; 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. Why Join Us
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth. You will work alongside leaders and colleagues who are passionate about fostering an inclusive, growth-centered culture and shaping the trajectory of BD. Through BD University, you will continually level up your technical skills and expertise. To learn more about BD visit https://bd.com/careers Primary Work Location
USA CA - San Diego (BDB); Additional Locations: IRL Limerick - Castletroy Work Shift BD is committed to investing in associates’ well-being and development, offering a competitive compensation and benefits package described on our Careers Site under Our Commitment to You. Salary information: Salary ranges depend on location and experience. The role may be Field-based or Remote.
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BD Biosciences is a world leader in providing innovative flow cytometry diagnostic and research tools. 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 focus on scientific rigor and regulatory compliance. This role requires advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D, and success across functions including Program Management, Marketing, Regulatory, Quality, and Medical Affairs to align scientific and logistical aspects of projects. By leveraging continuous improvement skills, this individual will identify opportunities to streamline development processes that comply with regulatory guidelines and accelerate launch timelines. The position also involves mentoring a team and representing BD externally at conferences, regulatory agencies, and with customers. Job Responsibilities
Advise on all matters related to clinical flow cytometry assay development. Assess technical feasibility of projects, identify risks, and propose solutions. Ensure scientific rigor for all technical and design reviews. Ensure compliance with BD’s Phase Gated Product Development System. Ensure R&D activities satisfy regulatory standards including documentation and reporting requirements. Collaborate across functions to ensure awareness and adherence to execution strategy and plans. Grow technical capabilities of the team through best practices, training, and mentoring. Provide succinct program updates to the program manager or other business leads as required. Represent BD externally at conferences, scientific meetings, and with regulatory agencies (e.g., FDA, notified bodies). Incorporate customer perspectives into product development and stay updated on emerging trends. Identify promising new clinically relevant technologies and/or assays; contribute to business strategy. Minimum Qualifications including Education and Experience
Advanced Degree (Masters or MD/PhD) in a relevant scientific field is required. Minimum of ten years of experience bringing clinical products to market. 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; ability to work effectively in a team and across geographies/time zones. Excellent verbal, written and presentation skills; 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. Why Join Us
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth. You will work alongside leaders and colleagues who are passionate about fostering an inclusive, growth-centered culture and shaping the trajectory of BD. Through BD University, you will continually level up your technical skills and expertise. To learn more about BD visit https://bd.com/careers Primary Work Location
USA CA - San Diego (BDB); Additional Locations: IRL Limerick - Castletroy Work Shift BD is committed to investing in associates’ well-being and development, offering a competitive compensation and benefits package described on our Careers Site under Our Commitment to You. Salary information: Salary ranges depend on location and experience. The role may be Field-based or Remote.
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