Operational Design Lead (US-Remote)

HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Operational Design LeadLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will lead study teams through the trial design process to drive delivery of a patient-centric, operationally integrated clinical trial protocol that is aligned with program strategy and timelines.Responsibilities

Serves as a Project Leader for the study design, protocol development, and operational plan development processes for late-stage studies across multiple therapeutic areas.

Partners with multiple cross-functional stakeholders to identify and advise on downstream operational impact of design options, study start up critical path considerations, and recruitment/retention implications. Seeks to enhance and optimize the execution of trials through strategic and forward-thinking collaboration with study management and feasibility functions.

Connects study teams to Amgen resources that can provide data and insights for data derived decisions and operational optimization.

Liaises closely with key team members to facilitate timely decision making that aligns with overall clinical development strategy.

Surfaces disconfirming information during the design process to ensure creation of a fit-for-purpose and efficient study design, considering operational and risk mitigations.

Partners with multiple cross-functional roles to ensure clarity of responsibilities and timely engagement and input. Identifies need for missing cross-functional input or data and facilitates effort to acquire it

Establishes detailed study design development timelines that align with regulatory and operational study timelines. Advises on critical path activities and risks to study start up timelines.

Advises on risk assessment and mitigation strategies and ensures operational plan development processes are in parallel with protocol development.

Defines and contributes to the continuous improvement of study design, feasibility and planning processes and study operational execution. Develop industry leading operational capabilities.

Identifies and demonstrates external knowledge of industry best practices, processes and new trends

WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The clinical professional we seek is a strong project manager with these qualifications.Basic Qualifications:

Doctorate degree and 2 years of clinical research experience OR

Master’s degree and 4 years of clinical research experience OR

Bachelor’s degree and 6 years of clinical research experience OR

Associate’s degree and 10 years of clinical research experience OR

High school diploma / GED and 12 years of clinical research experience

Preferred Qualifications:

9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company

A strong background in clinical operations or study feasibility

An understanding of the trade-offs between optimal study design to meet strategic objectives, operational efficiency and cost

Experience in leading cross-functional teams in a matrix organization

A project management skill set, with the ability to facilitate a team discussion to reach decisions and clear outputs

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 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.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 now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comApplication deadlineAmgen 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.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.