Clinical Scientist Director – Late Development, Inflammation
Portugal
Full Time
3 weeks ago
Visa Sponsorship
Key skills
LeadershipCommunicationPresentation Skills
About this role
Role Overview
Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials.
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, focusing on protocol execution and data integrity.
Work cross functionally to ensure clinical strategy is translated into the development of study documents.
Provide guidance and assistance in managing collaborators, consultants, and/or Clinical Research Organizations (CROs).
Review and analyze clinical trial data for accuracy, completeness, and adherence to protocol and regulatory requirements.
Ensure integrity of protocols for final governance approval.
Conduct thorough data quality assessments 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 late-phase drug development for Inflammation Development Therapeutic Area.
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 the Inflammation Development Therapeutic Area 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.