Director, Biomarker & Diagnostic Assay Development

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Overview of the role:

Title: Director, Biomarker & Diagnostic Assay Development

This is a Hybrid role on-site in one of the following ICON labs locations: Portland, OR; Cambridge, MA; Farmingdale, NY; or Lenexa, KS

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 quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON 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.

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