Operational Design Lead (US-Remote)

Career Category

Job Description

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 Lead

Live

What you will do

Let’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

Win

What we expect of you

We 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

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 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