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

Live

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 Oncology therapeutic area of Amgen. Will ensure 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. Will is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

Key Responsibilities:

• Drives the implementation and implementation of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas
• 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 (https://e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with 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 pharmaceutical/biotechnology R&D environment

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Life Sciences degree (higher qualification https://e.g. MSc or equivalent preferred).
• Further qualification, https://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)
• 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the https://U.S. is $135,103 - $166,357.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible
• Extensive clinical development experience of working in teams running clinical studies, particularly in the area of Oncology disease.
• 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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

https://careers.amgen.com

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Salary Range

135,https://103.00 USD - 166,https://357.00 USD