Danaher Corporation

The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.. This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote.. Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable. Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce.

director

Wondering what is within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We are building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you will see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we are working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the CCIA Clinical Affairs team and report to the Senior Director Clinical Affairs responsible for managing the CCIA portfolio for the Clinical Affairs department. If you thrive in a an amazing, multifunctional, fast paced role and want to work to build a world-class clinical affairs organization-read on.
In this role, you will have the opportunity to:
<ul>
<li>Accountable for planning, design, execution, and results of the Clinical Affairs Biomarker team & clinical trials program</li>
<li>Serve as primary clinical point of contact with the US FDA and other foreign regulators and notified bodies, and act as Clinical Lead for complex FDA negotiations leading to successful new product clearance and approvals for the Biomarker program</li>
<li>Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable</li>
<li>Develop and execute on a successful publication strategy for the biomarker program</li>
<li>Drive financial and operational performance of the clinical biomarker program</li>
<li>Partner with more junior and rising leaders to build resilient, resourceful, and strong succession ladders and to ensure the growth and development of those you manage</li>
</ul>
<h3>The essential requirements of the job include</h3>
<ul>
<li>Bachelor's degree with 20+ years of applicable experience or Master's/Doctoral degree with 18+ years of experience</li>
<li>6+ years of experience managing and developing people as well as managing complex clinical affairs budgets and site negotiations</li>
<li>Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks</li>
<li>Demonstrated success in managing highly complex multi-product, multi-technology portfolios of projects, globally highly preferred</li>
<li>Comprehensive knowledge of FDA & EU IVD regulations experience including a conversant knowledge of evolving China regulatory expectations</li>
<li>Nimble presentation skills for both planned and ad hoc presentations</li>
<li>Ability to travel approximately 25% as business needs dictate</li>
</ul>
<h3>It would be a plus if you also possess previous experience in</h3>
<ul>
<li>Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs</li>
<li>Extensive experience of successful application of diagnostic technologies (IVD) is highly preferred, as well as strategy development for Biomarkers</li>
</ul>
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 salary range for this role is $185,500 to $235,500. 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. We may ultimately pay more or less than the posted range. 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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