Job Description

The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the Amgen biomarker and diagnostics strategies. He/she ensures continuity and integrity across projects, coordinates assay development and implementation activities and acts 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 biosamples within one or more clinical projects or clinical studies. He/she is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

Essential Duties and Job Functions:

* Oversight of the Clinical Biomarker and Diagnostic Operations portfolio for the Oncology Therapeutic Area, including management of a team of CBD Operations Leads (contract workers/CWs)
* Drives the implementation and execution of the clinical biomarker and diagnostic plans for Oncology therapeutic programs in early and late stage clinical development
* Accountable for the development of a projects and/or clinical studys 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)/study(ies) and coordinates with internal and external partners (e.g., Bio-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 visits 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.

Basic Qualifications

Doctorate degree and 2 years scientific/industry experience

OR

Masters degree and 4 years scientific/industry experience

OR

Bachelors degree and 7 years scientific/industry experience

Preferred Qualifications

* Life Sciences degree (higher qualification e.g. MSc or equivalent preferred).
* Further qualification, e.g. project management certification is desirable.
* Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
* 5+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Experience, Skills, Knowledge

* Extensive clinical development experience of working in teams running clinical studies
* Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples
* Project management skills and knowledge of project management tools
* Critical reasoning skills including the identification and resolution of complex problems
* Detail oriented with the ability to work independently and manage multiple competing priorities
* Excellent planning, organizational and time management skills
* Effective communication skills