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Role Description

Join Amgen’s Mission of Serving Patients. In this role, the Clinical Scientist Associate Director supports late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities.

• Support set up and execution of late phase clinical trials with a focus on data quality.
• Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity.
• Provide input into and implementation of data management plan, CRF design, and data review oversight.
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission.
• Assist Development Lead and Clinical Scientist Director in medical monitoring and 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.

Qualifications

• 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

Requirements

• 3 years of pharmaceutical clinical drug development experience
• Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
• Industry or academic experience supporting late-phase drug development within a relevant therapeutic area or disease indication
• 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
• Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
• 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

Benefits

• 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 where possible

Salary Range

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is 183,251.00 USD - 223,386.00 USD.