Clinical Biomarker and Diagnostics Operations Lead

Clinical Biomarker and Diagnostics Operations Lead

02 Sep 2023
California, Southsanfrancisco, 94080 Southsanfrancisco USA

Clinical Biomarker and Diagnostics Operations Lead

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 LeadLiveWhat you will doLet’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 Inflammation and CardioMetabolic therapeutic areas of Amgen (General Medicine). 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 biosamples within one or more clinical projects or clinical studies. You will also be 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 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 (e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)

WinWhat we expect of youWe 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 degreeOrMaster’s degree and 3 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environmentOrBachelor’s degree and 5 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environmentOrAssociate’s degree and 10 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environmentOrHigh school diploma / GED and 12 years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environmentAndPrevious managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resourcesPreferred 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

Extensive clinical development experience of working in teams running clinical studies, particularly in the areas of either Inflammation or CardioMetabolic 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

ThriveWhat you can expect of usAs 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 U.S. is $135,103 - $166,357. The annual base salary range for this opportunity based in South San Francisco is $147,732 - $174,241.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

Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

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