Director r&d - clinical assay / cdx development

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 new role is ideal for someone who thrives in environments that require both deep technical insight and robust leadership / influencing skills.

If you're passionate about pushing the boundaries of clinical diagnostics and want to make an impact on the global stage-while mentoring a team and shaping the future of medical technology-this position offers a rich canvas for growth and innovation.

The role requires advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D.

As a subject matter expert in these areas, this individual is expected not only to understand R&D requirements but also to possess an in-depth knowledge of product characterization, verification and validation activities, as well as the regulatory landscapes that guide these activities.

By working successfully across functions-including Program Management, Marketing, Regulatory, Quality, and Medical Affairs-this leader will ensure both the scientific and logistical aspects of projects are seamlessly aligned.

This collaborative approach is critical for creating detailed critical path maps and integrated program dependency plans that keep projects on schedule and on budget.

Additionally, by leveraging continuous improvement skills, this individual will identify opportunities to streamline current development processes that comply with regulatory guidelines, with the goal of accelerating launch timelines.

Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world.

Advancing the world of health is our Purpose, and it's no small feat.

It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve.

Join us and discover an environment in which you'll be supported to learn, grow and become your best self.

Become a maker of possible with us.

We are the makers of possible BD is one of the largest global medical technology companies in the world.

Advancing the world of health is our Purpose, and it's no small feat.

It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve.

Join us and discover an environment in which you'll be supported to learn, grow and become your best self.

Become a maker of possible with us.

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 new role is ideal for someone who thrives in environments that require both deep technical insight and robust leadership / influencing skills.

If you're passionate about pushing the boundaries of clinical diagnostics and want to make an impact on the global stage-while mentoring a team and shaping the future of medical technology-this position offers a rich canvas for growth and innovation.

The role requires advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D.

As a subject matter expert in these areas, this individual is expected not only to understand R&D requirements but also to possess an in-depth knowledge of product characterization, verification and validation activities, as well as the regulatory landscapes that guide these activities.

By working successfully across functions-including Program Management, Marketing, Regulatory, Quality, and Medical Affairs-this leader will ensure both the scientific and logistical aspects of projects are seamlessly aligned.

This collaborative approach is critical for creating detailed critical path maps and integrated program dependency plans that keep projects on schedule and on budget.

Additionally, by leveraging continuous improvement skills, this individual will identify opportunities to streamline current development processes that comply with regulatory guidelines, with the goal of accelerating launch timelines.

Job Responsibilities : 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 BDB's 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 BDB externally at conferences and scientific meetings.

Represent BDB 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 strategy.

Minimum Qualifications including Education and Experience : Advanced Degree (Masters or MD / Ph D) in a relevant scientific field is required.

Minimum of ten years' 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.

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.

Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.

You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

And through the organization's investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health.

At BD, you'll discover a culture in which you can learn, grow and thrive.

And find satisfaction in doing your part to make the world a better place.