Operational Design Lead - Clinical Research & Trials - Remote US

Job Description

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Remote CONUS AK HI

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

Auto req ID

424973BR

Minimum Education Required

High School/GED

Job_Category

Pharmaceutical

Additional Qualifications/Responsibilities

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

Salary Range

143,548.00 USD - 172,458.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen