Clinical Scientist Director, Early Development Oncology
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Overview
As a Clinical Scientist Director in Early Development Oncology, you translate scientific strategy into actionable clinical execution in early-phase trials. You provide hands-on oversight of protocol execution, data quality, and medical data review to enable decision-ready data. You collaborate across cross-functional teams to align trials with protocol intent, regulatory expectations, and Amgen standards. You contribute medical monitoring, data interpretation, and governance with CROs and external partners. This role offers the chance to shape oncology development and impact patient outcomes within a collaborative, science-driven culture.
Compensaciones / Beneficios Retirement and savings plan
group medical, dental and vision coverage
life and disability insurance
discretionary annual bonus program
stock-based long-term incentives
flexible work models (remote and hybrid)
Responsabilidades
Oversee protocol execution and data quality in early-phase oncology trials
Contribute to medical monitoring and assessment of subject-level data to identify risks and issues
Collaborate across cross-functional teams to translate clinical strategy into study concepts and documents
Provide guidance in managing collaborators, consultants, and CROs for key projects
Ensure protocol integrity and governance for clinical plans and final deliverables
Review and analyze trial data for accuracy, regulatory compliance, and completeness
Conduct data quality assessments within a data monitoring plan across the trial lifecycle
Support regulatory submissions and high-level clinical regulatory responses
Draft and contribute as an author to publications and conference presentations
Utilize data analysis tools (e.g., Spotfire) for clinical data interpretation
Requisitos principales Doctorate, 4+ years in life sciences/healthcare OR Master's, 7 years OR Bachelor's, 9 years (substantial clinical drug development experience)
Experience in pharmaceutical early-phase oncology development
Strong communication and presentation skills for leadership audiences
Experience designing, monitoring, and implementing oncology clinical trials under GCP
Ability to perform data readouts, data cleaning, and outputs for regulatory or internal use
Experience drafting regulatory submission materials and responses
Contributing author experience for scientific publications and conferences
Familiarity with Spotfire or similar data analysis tools
clear communicator
cross-functional collaboration
problem solving
clinical trial design and execution
data interpretation and statistics basics
GCP regulatory knowledge
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