Director, Clinical Affairs US

2 weeks ago

New Brighton, Minnesota, United States Danaher Full time

In our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating impactful innovations like ours, doesn't happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

The US Clinical Affairs Director for Radiometer Acute Care Dx is responsible for building and leading the US-based Hub of the Clinical and Medical Affairs (CMA) organization. The US-based Hub will play a major role in the clinical program supporting EU and US regulatory approvals and Radiometer global business objectives.

This position is part of the Clinical & Medical Affairs department of which the EU Hub is located in Brønshøj (Denmark) and the US Hub in Minneapolis. This position will report to the Sr. Director Clinical & Medical Affairs and be based out of New Brighton, MN in a hybrid role.

At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. If you thrive in an exciting leadership role and want to work to build a world-class Clinical organization, read on.

In this role, you will have the opportunity to:

  • Be part of the CMA Leadership Team (CMALT) and contribute to the direction and development of the C&MA function and its leadership
  • Build the US Clinical Affairs organization and drive its performance and results through DBS tools
  • Develop peer-level relationships and collaboration with internal stakeholders across Radiometer and other OpCo's in consistent alignment with the overall company strategy and objectives
  • Act as subject matter expert on clinical operations (planning, execution, outsourcing) towards the obtention of FDA approval to support the different product areas from early development to product end-of-life
  • Execute the clinical studies that relate to FDA submissions and that involve US sites
  • Ensure accurate, complete and on-time budget and expense data is provided by the study managers and other relevant functions. Ensures correct forecasting, budget allocation and financial tracking related to clinical studies
  • Team up with the Director of Clinical Affairs EU and RoW to ensure the global clinical strategy and execution alignment and act as a resource for colleagues with less experience and/or a dissimilar professional background

The essential requirements of the job include:

  • Bachelor of Science (BS), Master of Science (MS) or Doctor of Philosophy (PhD) Degree in biomedical/life sciences and more than 5 years of experience in clinical or scientific leadership role within device industry, preferably in IVD and/or MD
  • Knowledge of US requirements and regulations related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies
  • Proven track record of delivering results "through" a team and creating team engagement
  • Ability to build strong relations and trust with global internal and external stakeholders
  • Experience with lean principles, problem solving, Daily Management/Visual Management, action plans, ability to prioritize the critical few
  • Travel up to 20%

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

  • Demonstrated commercial release of IVD/MD products related IVD
  • Implementation of AI to support the generation of clinical documentation

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

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

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.

The EEO posters are available here.

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 to request accommodation.

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