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Clinical Biomarker and Diagnostics Operations Lead

Employer
Amgen
Location
Thousand Oaks, California
Start date
Nov 14, 2023

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets 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 bio samples 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 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) and coordinates with internal and external partners (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

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

Or

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

Or

Associates 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 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)
  • 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.

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.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Telephone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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