Job Summary
We are seeking a Technical Director to lead the development of innovative flow cytometry-based clinical assay projects. As a key technical leader, you will be responsible for making informed recommendations on all development aspects, from concept through to commercialization, with a focus on scientific rigor and regulatory compliance.
This role is ideal for someone who thrives in environments that require both deep technical insight and robust leadership skills. If you are passionate about pushing the boundaries of clinical diagnostics and want to make an impact on the global stage, this position offers a rich canvas for growth and innovation.
The successful candidate will have advanced, hands-on experience in flow cytometry applications and clinical diagnostic R&D. They will possess an in-depth knowledge of product characterization, verification, and validation activities, as well as the regulatory landscapes that guide these activities.
You will work collaboratively across functions, including Program Management, Marketing, Regulatory, Quality, and Medical Affairs, to ensure both the scientific and logistical aspects of projects are seamlessly aligned. This approach is critical for creating detailed critical path maps and integrated program dependency plans that keep projects on schedule and on budget.
In addition, you will leverage continuous improvement skills to identify opportunities to streamline current development processes that comply with regulatory guidelines, with the goal of accelerating launch timelines.
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 regulatory standards, including documentation and reporting requirements.
* Collaborate and communicate effectively across all functions to ensure 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 the organization externally at conferences and scientific meetings.
* Engage with related industrial and medical institutions to stay updated on emerging trends in the field.
Requirements
* Advanced Degree (Masters or MD/PhD) 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.
Why Join Us?
A career at our organization means being part of a team that values your opinions and contributions and 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 our organization while leaving a legacy at the same time.
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.