Clinical Scientist Director - Early Development, Oncology

Clinical Scientist Director - Early Development, Oncology

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 early 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;
• 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.

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 early-phase drug development within Oncology;
• 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 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.