Director, Biomarker & Diagnostic Assay Development

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Overview of the role:

Title: Director, Biomarker & Diagnostic Assay Development

Location: Portland OR (Hybrid)

Duties:

• Establishment of policies and procedures for development of new assays and technologies in molecular biology to support biomarker analysis in clinical trials • Development and delivery of leading edge scientific and technical capabilities

 • Assessment of new products and services to address customers’ assay requirements that are appropriate for the intended use of the test results

 • Establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system

• Provide consultation and troubleshooting support for molecular assays following implementation in clinical trial testing

• Inform the Business Development and Marketing teams regarding capabilities of ICON Laboratories for performing custom and commercial assays for clinical trial testing

• Provide scientific thought leadership through publications and presentations • Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients and Performance

 • As a People Leader, the employee is expected to recognize the importance of creating a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting sponsor needs • Travel (approximately 5%) domestic and/or international

 • Provide strategic leadership to the Assay Development/Validation Function – build and implement a strategic plan comprising all relevant technical, operational, and resourcing needs. • Lead or contribute to cross-functional initiatives and teams where requested.

 • Ensure that Assay Development/Validation activities and budget are managed efficiently and effectively, and these processes are continuously improved upon

• Lead regular review of SOPs to ensure they remain relevant, current, and are being followed. Recommend policies, procedures, and processes to ensure that a high level of efficiency, QC, and QA is maintained

 • Performs additional relevant responsibilities as requested

To be successful in the role, you will have:

 •PhD preferred in Cell Biology, Molecular Biology or Biochemistry

 •Minimum of 6 to 9 years of experience in industry with a focus on PCR methods and clinical biomarker assay design and development.

 •Prior experience leading a team of scientists.

 •Strong leadership and communication skills.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.