Senior Manager, Clinical Affairs in Brea, California at Beckman Coulter Diagnostics

Date Posted: 11/11/2019

Job Snapshot

Job Description

Job ID: BEC016208

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


The Senior Manager,  Clinical Affairs will oversee and manage all sepsis clinical studies that fall under the oversight of the Danaher Diagnostics Sepsis Initiative.  While the reporting line is embedded within the Beckman Coulter operating company, the position is responsible for overseeing clinical studies that may also involve products from the Danaher diagnostic companies of Radiometer and Cepheid.  By positioning the different Danaher company’s sepsis product lines together through a robust clinical evidence strategy, there is an exciting opportunity to make a greater impact in improving clinical outcomes for patients with sepsis.  Further, the position will work closely with the Danaher Diagnostics digital team to incorporate machine learning predictive analytic algorithms into real-world evidence study designs. 

Essential Duties and Job Responsibilities:
• Sets the clinical evidence strategy for design of studies of new innovative sepsis products. Also responsible for strategy for generating clinical evidence for combined Danaher portfolio of sepsis products. 
• Collaborates with potential investigators/clinical partners to further feasibility of new sepsis products
• Serve as the sepsis clinical evidence workstream lead for the cross-functional, cross-operating company Danaher Diagnostics sepsis initiative team, providing monthly report-outs on progress related to implementation and execution of Danaher’s sepsis regulatory & clinical evidence strategy to Director of the Danaher Diagnostics sepsis initiative and internal sepsis steering committee. 
• Ensures timely completion of clinical trials within budget and committed timelines
• Manages team responsible for all aspects of the clinical process, from clinical study protocol (that adhere to Good Clinical Practices & FDA & IVDR guidelines) and oversees  from site selection/qualification, site readiness/site visits, participating in investigator meetings as needed
• Interfaces and works closely with Biostatistics group to guide post-study data analysis including support in drafting technical disclosure agreements and provisional patent filings in close collaboration with IP/legal team
• Partners with Regulatory Affairs team member to ensure alignment of clinical & regulatory strategies as well participates in negotiations with FDA. Submissions to include innovative approaches utilizing real-world evidence and digital diagnostic algorithms. Negotiates to support FDA submissions & ROW registrations. Negotiates with FDA in collaboration with regulatory team member which may include submissions with digital diagnostic algorithms and real-world clinical evidence
• Responsible for clinical evidence publication strategy for Danaher sepsis initiative. Partners with  clinical investigators, Product Management & other stakeholders  to ensure successful peer-reviewed publications. Develops strategy to employ meta analyses and consideration of all data sources to further product claims.
• Stays current with sepsis disease state and related therapies literature and standard of care guidelines

Job Requirements


• ≥5 years industry experience in clinical studies in IVD regulated diagnostics/medical device industry or experience with companion diagnostics and collaboration with pharma
• Bachelor’s degree with 9+ years’ experience, Master’s with 7+ years’ experience, or Doctoral degree with 5+ years in Immunology, Molecular or Cell Biology, Biochemistry or a related field 
• Experience designing, organizing and conducting complex clinical trials
• Experience in review of statistical analysis of clinical data, writing summary reports and technical articles for publication in professional journals
• Experience with complex regulatory (FDA) submissions 
• Experience in IVD product development a plus
• Experience with sepsis disease state/studies a plus
• Experience with utilizing algorithms and/or real-world evidence to prove clinical outcomes a plus
• Experience with planning, designing, and executing adjudication process
• Able to travel up to 30-50% of the time 

Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.