Amgen

Clinical Scientist Director – Early Development, Inflammation

Amgen

full-time

Posted on:

Location Type: Hybrid

Location: Lisbon • Portugal

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Job Level

Lead

About the role

  • Support early phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials.
  • Serve as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality.
  • 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), their delivery, clinical data review, 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

  • Doctorate degree and 4 years of life sciences/healthcare experience OR Master’s degree and 7 years of life sciences/healthcare experience OR Bachelor’s degree and 9 years of life sciences/healthcare 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 Inflammation
  • Strong communication & presentation skills in English 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 for Inflammation 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
  • Vast opportunities to learn, develop, and move up and across our global organization.
  • Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
  • Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
  • Flexible work arrangements.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial designclinical data reviewdata quality assessmentclinical monitoringdata analysisprotocol executionregulatory complianceGood Clinical Practiceclinical drug developmentdata cleaning
Soft Skills
communication skillspresentation skillscollaborationproblem managementleadershipinterpersonal skillsorganizational skillsscientific expertisecritical thinkingproject management