Clinical Biomarker Lead

As a Sr Biomarker Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

The Senior Specialist, Biomarker Operations will be a highly motivated scientist working in a dynamic, cross-functional environment within the clinical development team to implement biomarker strategies for clinical assets. The successful candidate will be a strategic, hands-on leader that supports all aspects of biomarker development and execution, including patient selection, pharmacodynamic, and clinical response biomarkers. The candidate will utilize internal and external interactions to support clinical biomarker utilization and contribute towards the successful development and execution of the biomarker plan for a given program.

Key Responsibilities:

We are seeking a highly motivated professional to join our Biomarker Operations group to work in a dynamic and cross-functional environment spanning early to late-stage clinical development. The Senior Specialist, Biomarker Operations acts as an important contributor to clinical development of novel therapies to treat rare diseases.

In this position you will coordinate timelines and activities for biomarker projects to ensure high quality and timely delivery of biomarker results and maintain close contact with the Biomarker and Imaging program leadership to communicate activities. This role will closely collaborate with biomarker leads, clinical trial operations, medical, data management, biostatistics, and external laboratory vendors/CROs. Core duties of this role include biomarker sample operational logistics, clinical trial support, and management of biomarker vendors.

Responsibilities:

• Work with colleagues in the Biomarkers Department for the implementation of biomarkers in pre-clinical validation and clinical studies to meet program goals through a translational understanding of the disease state and treatment modalities
• Serve as a key member of clinical study execution teams, providing input and guiding clinical implementation of biomarkers
• Develop biomarker sample handling guideline for sample processing and manage aspects of biomarker sample collection and consent
• Track and trigger analyses of biomarker clinical samples to completion and data transfers according to established timelines
• Resolve biomarker sample related questions from sites, CROs, clinical operations, and ethics committees with cross-functional team input (e.g. stability, sample usage, storage duration)
• Manage work with CROs on biomarker assays (for pre-clinical development and validation or on clinical trials) including contract management, scope of work, lab manual, biomarker analysis plan, development of timelines, and oversight of deliverables
• Responsible for long term storage and destruction of biomarker samples from clinical or exploratory studies
• File expected biomarker documents in sponsor Trial Master File (TMF)
• Review clinical trial study documents including study dossier, version control tracker, vendor management plan, and Action Decisions Risks log and update as applicable.
• Assists with oversight of and maintaining budget for assigned biomarker projects
• Participate in process improvement projects (e.g., SOPs, work instructions, training materials, etc.) for biomarker management
• Review sections of clinical study protocol, biomarker strategy documents, and biomarker study reports with supervision

You are:

• BS in Biology or related field with 4 or more years of experience or the equivalent combination of education and experience
• Excellent written and oral communication; organized and detail-oriented; ability to prioritize and plan
• Knowledge and understanding of general scientific principles as applied to biomarker research, development, and implementation
• Knowledge of Good Clinical Practices, clinical study design and implementation is required

Why 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.

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.

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, colour, 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.

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.