Clinical Scientist Director - Late Development, Inflammation

Amgen

Lisbon or Remote

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role, the Clinical Scientist Director will support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials. The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data. The Clinical Scientist works collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards.

Key Responsibilities:

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;
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents;
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects;
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;
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval;
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues;
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;
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Minimum 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.

Preferred Requirements:

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, data base 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.