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Danaher Corporation Staff Clinical Research Scientist in Deer Park, Illinois

Mammotome and Leica Biosystems mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. When you join our team, you’re collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes.

As part of the Global Clinical Affairs team at Leica Biosystems, this position is responsible for supporting Mammotome's suite of breast cancer diagnostics and surgical solutions.

Leica Biosystems and Mammotome are 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 Staff Clinical Research Scientist works closely with the Global Clinical leadership team to develop and execute comprehensive evidence plans to support global growth initiatives. The role requires leading global evidence initiatives to support new product development, pre and post-market studies, and internal evidence development processes across multiple functions within Medical Device and/or IVD.

Responsibilities we will trust you with:

  • Evidence strategy – synthesis of Voice of Customer requirements into recommended evidence investments. Comprehensive evidence plan for all priority products and markets to meet customer needs and drive market awareness/adoption.

  • Study design – protocol writing, enrollment strategy, collaboration on statistical analysis plan/data management plan, monitoring plan writing

  • Study conduct – supports the clinical operations team with the conduct of clinical studies

  • Study reporting – data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications

  • Providing direction and task oversight to others on the clinical team for one or more programs

  • Leads the investigator initiates study and medical/clinical information request processes

  • Provides oversight and approval for select marketing claims and materials

The role involves collaborations with internal project stakeholders (Product Development, Clinical Affairs, R&D, Quality, Regulatory, Health Economics and Reimbursement, Medical Affairs, etc.) and external partners (such as co-development collaborators and CROs).

Your areas of knowledge and expertise that matter most for this role:

  • Bachelor of Science (B.S.) or Master of Science (M.S.) or Doctor of Philosophy (Ph.D.). and a minimum of the following years of industry or relevant experience according to degree:

  • Bachelor's Degree with 10+ years; Or,

  • Master's degree with 7+ years; Or,

  • Doctoral degree with 5+ years.

  • Demonstrated experience in creating global evidence plans to support new product development, developing clinical strategy, study design/execution, and study monitoring for medical devices in a regulated environment.

  • Demonstrated experience in effectively negotiating with regulators (such as the U.S. Food and Drug Administration) and designing/executing clinical programs resulting in a successful global commercial release.

  • Demonstrated strong ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.

  • Demonstrated strong ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities.

  • Demonstrated ability or track record of successful results, building effective teams, and getting work done through others.

Travel: Up to 40% (in non-COVID times)

What we have to offer:

Check out our benefits here: https://danaherbenefitsinfo.com/

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.

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#LI-REMOTE

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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 (https://www.dol.gov/agencies/ofccp/posters) .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. If you’ve ever wondered what’s within you, there’s no better time to find out.

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