Clinical Scientist Associate Director – Early Development Inflammation

About the role

Join Amgen’s mission of serving patients. This role supports Inflammation early clinical development by contributing to protocol development, study start-up, data review and monitoring, and analysis activities.

Responsibilities

• Support set up and execution of early phase clinical trials with a focus on data quality.
• Assist in authoring clinical protocols, Investigators Brochures, and other regulatory documents ensuring consistency and clarity.
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission.
• Supports the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects.
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams.
• Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents.
• Support appropriate training, recruitment, and development requirements for matrix team resources.

Requirements

• Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience

Qualifications

• 3 years of experience in a pharmaceutical industry setting with at least 1 year supporting early or late-phase clinical development within a relevant therapeutic area or disease indication.
• Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment.
• Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral.
• Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements.
• Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance.
• Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences.
• Experience in clinical data analysis such as Spotfire or other data analysis tools.

Skills

Not specified

Benefits

Not specified

Pay

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.

Schedule

Not specified