Clinical Sciences Director – Early Development, Oncology

Amgen

Clinical Sciences Director role at Amgen focuses on early-phase clinical development in Oncology. Ensuring high-quality protocol execution and collaboration with cross-functional teams.

Posted 5/22/2026full-timeRemote • 🇺🇸 United StatesLead💰 $211,176 - $285,709 per yearWebsite

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Hard Skills

clinical developmentclinical trial process improvementdata quality assessmentclinical data analysisprotocol executionmedical data reviewregulatory compliancedata monitoring planstudy protocol developmentclinical input implementation

Soft Skills

communication skillspresentation skillscollaborationproblem managementleadershipinterpersonal skillsorganizational skillsanalytical skillsteamworkadaptability

Tools & Technologies

Spotfireclinical trial management systemsdata analysis toolsGood Clinical Practice standardsregulatory submission documentsdatabase lockdata extractclinical research organizations (CROs)study concept documentdata outputs

Industry Keywords

Oncologyearly-phase drug developmentclinical trialspharmaceutical developmentscientific publicationsdata integrityclinical monitoringhealth regulatory interactionsclinical data reviewdecision-ready data

About the role

Key responsibilities & impact

support early-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials
Provide hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data
work collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

Requirements

What you’ll need

Doctorate degree and 4 years of clinical development experience OR Master’s degree and 7 years of clinical development experience OR Bachelor’s degree and 9 years of clinical development experience
5 years of pharmaceutical clinical drug development experience
Strong preference for individuals with proven track record of clinical trial process improvement
Industry or academic experience in early-phase drug development within Oncology
Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
Experience with designing, monitoring, and implementing clinical trials within Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
Serving as a contributing author to scientific publications and data presentations at scientific conferences
Experience in clinical data analysis such as Spotfire or other data analysis tools

Benefits

Comp & perks

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