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Clinical Biomarker and Diagnostics Operations Senior Associate

2 months ago

Washington DC, United States Amgen Full time

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Biomarker and Diagnostics Operations - Senior Associate

What you will do

Lets do this. Lets change the world. In this vital role you will support the 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.

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 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)

  • 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

  • Contributes to 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.

    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 self starter with these qualifications.

    Basic Qualifications:

  • Masters degree OR

Bachelors degree and 2 years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR

Associates degree and 4 years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment OR

High school diploma / GED and 6 years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

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)

2+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Prior 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

Meticulous with the ability to work under general direction and manage multiple competing priorities

Excellent planning, organizational and time management skills

Effective communication skills

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

A 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

Flexible work models, including remote and hybrid work arrangements, where possible

Apply now for a career that defies imagination

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

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.