Clinical Scientist Associate Director, Rare Disease- Autoimmune/Inflammation Job at Amgen

Job Description

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. Working collaboratively with the study team and clinical leadership, this role focuses on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data.

Job Responsibility

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
Assists 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

Requirements

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

Nice to have

3 years of pharmaceutical clinical drug development experience
Experience in Rare disease, autoimmune or inflammation clinical development
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

What we offer

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

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Clinical Scientist Associate Director, Rare Disease- Autoimmune/Inflammation

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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