Associate Medical Science Director - Late Development, Oncology
Amgen
Full-time
Remote friendly (United States)
United States
Clinical Research and Development
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Role Summary
Associate Medical Science Director - Late Development, Oncology
Responsibilities
- 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 & 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 Medical Sciences Director in medical monitoring and management of oncology phase 3 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
- Basic Qualifications:
- Doctorate degree and 3 years of clinical research experience
- OR Master’s degree and 5 years of clinical research experience
- OR Bachelor’s degree and 7 years of clinical research experience
- OR Associate’s degree and 12 years of clinical research experience
- OR High school diploma / GED and 14 years of clinical research experience
- Preferred Qualifications:
- 3 years of pharmaceutical clinical drug development experience
- Industry or academic experience in late-phase oncology drug development
- Experience cleaning or managing data for a Phase 3 clinical study or regulatory filing
- Proven ability to think creatively and develop innovative strategies beyond standard clinical scientist approaches
- Demonstrated initiative and problem-solving skills in dynamic, cross-functional team environments
- Extensive experience monitoring, cleaning, reviewing clinical trial data and developing medical data review plans
- Experience serving on cross functional team and demonstrated ability to collaborate with clinical ops though the conduct of a study
- Experience in clinical data analysis such as Spotfire or other data analysis tools
Skills
- Medical monitoring and data interpretation in oncology late-phase studies
- Regulatory documentation and protocol development
- Cross-functional collaboration and project leadership
- Data management planning and data review oversight
- Analytical thinking and problem-solving in dynamic environments
Education
- Doctorate, Master’s, Bachelor’s, Associate’s, or equivalent required as specified in Basic Qualifications