Principal Clinical Scientist

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Beckman Coulter Diagnostics one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

As a global leader in clinical diagnostics Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing and are used in hospitals reference and research laboratories and physician offices around the world. Every hour around the world more than one million tests are run on Beckman Coulter Diagnostics systems impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough to rapid and reliable sample analysis to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency clinical confidence adaptive collaboration and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

The Principal Clinical Scientist responsible for clinical trial strategies within the US and EU regions for Beckman Coulter.

This position reports to the Senior Manager Clinical Science and is part of Beckman Coulter Inc. Hematology and Urinalysis business unit located in Miami FK and will be fully remote

In this role you will have the opportunity to:

• Design clinical studies and evidence strategies supporting global regulatory submissions (e.g. FDA 510(k)/PMA CE IVDR) across multiple diagnostic modalities.
• Act as a scientific and clinical liaison with regulatory bodies key opinion leaders and external sites to develop protocols claims and evidence plans.
• Partner cross functionally with R&D Regulatory Medical Affairs Quality and Commercial teams to align clinical programs with product development and market access needs.
• Author and review clinical and regulatory documentationincluding study reports technical files and publicationsto support product clearance and commercialization.
• Build strong internal and external collaborations mentor junior scientists and maintain expertise in evolving regulatory standards clinical guidelines and diagnostic technologies.

The essential requirements of the job include:

• Bachelors degree in Life Sciences Healthcare or a related filed with 9 years of experience in clinical research specifically with significant experience in US and/or EU trials or a Masters degree with 12 years of experience or Doctoral degree with 4 years of experience
• In-depth understanding of clinical study design and methodology in the diagnostics medical device or pharmaceutical industry with products intended for the US and EU markets
• Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation
• Ability to critically review and interpret scientific and clinical trial data and oversee the scientific aspects of study protocols and reports
• Excellent communication (written and verbal) and interpersonal skills for collaborating with cross-functional stakeholders.

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 10% overnight within US and/or EU
• Must have a valid drivers license with an acceptable driving record

It would be a plus if you also possess previous experience in:

• Experience in study designs for diagnostic technologies (IVD) is highly preferred specifically for Hematology and Urinalysis
• Advanced degree in Science Healthcare or Regulatory/Clinical Affairs
• Professional certification in Clinical Research (e.g. SoCRA ACRP)

Beckman Coulter Diagnostics a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Beckman Coulter Diagnostics we believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home.

Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

The annual salary range OR the hourly range for this role is $130000-$150000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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