Clinical Scientist Associate Director – Late Development
What You Will Do
- 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.
- Provide input into and implement 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 in management of collaborators, consultants, and/or Clinical Research Organizations for key projects.
- Anticipate and actively manage problems across cross-functional teams.
- Translate clinical strategy into the development of study concept document, study protocol and related documents.
- Support training, recruitment, and development requirements for matrix team resources.
Basic Qualifications
- Doctorate degree and 3 years clinical development experience
- OR Master’s degree and 5 years
- OR Bachelor’s degree and 7 years
- OR Associate’s degree and 12 years
- OR High school diploma/GED and 14 years
Preferred Qualifications
- 3 years pharmaceutical industry; at least 1 year early or late-phase clinical development in relevant therapeutic area/disease (oncology preferred)
- Experience contributing to clinical trial process improvements
- Strong written/oral communication and presentation skills
- Experience supporting clinical trials in compliance with GCP and applicable regulations
- Working knowledge of study data readout (data cleaning, database lock, data extraction, clinical outputs)
- Experience supporting regulatory submission documents and health authority responses under guidance
- Contributing author experience on publications or conference/data presentations
- Experience in clinical data analysis (e.g., Spotfire or other tools)
Benefits (explicitly stated)
- Total Rewards Plan: health/welfare, retirement/savings options, work/life balance, career development; includes retirement plan contributions, medical/dental/vision, life/disability, flexible spending accounts, bonus/incentive plan, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient number/select candidate. Sponsorship not guaranteed.