Director of Channels, Partners and Agencies
Ascend Technologies
Associate Medical Science Director – Late Development, Oncology
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $168,998 - $208,064 per year
Job Level
Lead
About the role
- Contribute to late phase clinical development of oncology compounds from first-in-human studies through proof of concept
- Collaborate on teams to support defining, design, and delivery of late phase clinical and translational projects
- Support 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 & 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
Requirements
- 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
- 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
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
- 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, including remote and hybrid work arrangements, where possible
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchdata managementclinical trial monitoringdata analysisprotocol developmentregulatory submissiondata quality assurancemedical data reviewoncology drug developmentPhase 3 clinical study
Soft skills
problem-solvingcreativityinitiativecollaborationcross-functional teamworkcommunicationorganizational skillsleadershiptrainingdevelopment
