BioMarker Technical Expert

Biomarker Technical Expert

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The primary responsibility of this role is to provide biomarker technical expertise and support to the Translational Science Lead (TSL) to ensure operational implementation and execution of translational science strategies in clinical trials which may include phase I, II and III studies.

Responsible for all operational and logistical aspects of carrying out biomarker related activities to ensure timely

and quality data delivery.

What You Will Be Doing:

• Collaborate closely with TSL, Clinical Operations, Biostatistics/Bioinformatics, and data management teams to support and execute translational science strategies in clinical trials

• Develop and provide operational input into all study related documentation and processes, and ensure collection, delivery and analysis of biomarker samples in compliance with these documents as well as GCP/ICH

• Serve as a single point of contact for biomarker operations across functions, and with collaborators and CROs.

• Provide biomarker operational expertise and guidance to the study teams and ensure learnings are taken across teams (studies, programs); identify areas of best practice and process improvements

• Work with data management for set-up and application of biomarker-relevant pages, coordination of biomarker data format and delivery timelines, data transfer specification setup, to ensure timely and efficient data delivery (data transfers, reconciliation, analysis, reports), mutual data transfers with Companion Diagnostics (CDx) partners for CDx regulatory submissions, if needed

• Lab vendor management including contracting, data QC and delivery timelines, data transfers and reporting

• Manage implementation and execution of clinical biomarker sample logistics and operations including site feasibility and training, sample management plan, lab manual, monitoring of proper delivery

• Provide real-time sample oversight and drive ongoing sample reconciliation to support selection of samples for analysis

Your Profile:

• Bachelor's degree with 5+years pharmaceutical or biotechnology industry experience required; Doctoral-level degree with 3+ year relevant experience and discipline or Master's degree with 5+ years in a relevant experience and discipline preferred.

• Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development and precision medicine

• Clinical laboratory experience including involvement in the processing and/or analysis of clinical samples

• Project management skills including planning, organizational and time management skills

• Global vendor management experience

• Critical reasoning skills including identification and resolution of complex problems

• Detail oriented with the ability to work independently and manage multiple competing priorities

• Proven project leadership skills, ability to successfully achieve results within multi-cultural and geographically diverse teams

• Excellent oral/written communication skills

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply