Clinical Biomarker and Diagnostics Operations Lead

Career Category

Clinical Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Clinical Biomarker and Diagnostics Operations Lead

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What you will do

Let’s do this. Let’s change the world. In this vital role you will plan and coordinate all project management and operational activities required to operationalize the Amgen biomarker and diagnostics strategies for programs in the Oncology therapeutic area of Amgen. You will ensure continuity and integrity across projects, coordinate assay development and implementation activities and act as the primary point of contact for CBD operations for projects requiring biomarker and diagnostic activities including collection, delivery and analysis of biomarker and diagnostics biospecimens within one or more clinical projects or clinical studies. You will also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

• Drives the implementation and execution of the clinical biomarker and diagnostic plans for programs in early and late stage clinical development across the Oncology therapeutic area

• Accountable for the development of a project’s and/or clinical study’s biomarker and diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness

• Accountable for project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies

• Accountable for planning and implementing the biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc

• Accountable for ensuring that data received is consistent with collection and assay plan and protocols

• Serves as first point of contact for biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinates with internal and external partners (e.g., Biological Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)

• Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s)

• Provide regular reports on sample tracking to select samples for analysis based on varying criteria

• Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.

• Participate in site initiation presentations to train sites on sample collection

• Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/data results and is a key contact for the assay lab.

• Project manages contracts, budgets and timelines for biomarker/Dx activities within studies to ensure timely completion of biomarker and diagnostic activities.

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leaderwith these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Or

Bachelor’s degree and 5 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Or

Associate’s degree and 10 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Or

High school diploma / GED and 12 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharm