Clinical Scientist Director – Late Development Oncology

This is a fully remote position, open to applicants in Spain.

📋 Description

• Assist in late-phase clinical development by converting scientific and clinical strategies into actionable execution across clinical trials.

• Provide direct oversight of protocol execution, medical data evaluation, and the quality of clinical data.

• Ensure that clinical trials are conducted in accordance with the intended protocol, regulatory requirements, and Amgen’s quality standards.

• Act as a clinical and scientific subject-matter expert for the designated therapeutic area and disease indication, emphasizing protocol execution and data integrity.

• Participate in medical monitoring activities and support the ongoing evaluation of subject-level clinical data to identify trends, risks, and emerging issues.

• Present information internally and externally, proactively managing problems across a wide range of cross-functional teams.

• Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs).

• Collaborate across functions to ensure the clinical strategy is effectively translated into the development of the study concept document, study protocol, and related documentation.

• Review and assess clinical trial data for accuracy, completeness, and compliance with protocol and regulatory standards.

• Conduct comprehensive data quality assessments within a data monitoring plan to uphold high standards of data accuracy and integrity throughout the trial lifecycle.

⛳️ Requirements

• Doctorate degree with 4 years of experience in life sciences or healthcare, OR Master’s degree with 7 years of experience, OR Bachelor’s degree with 9 years of experience in life sciences or healthcare.

• Minimum of 5 years of experience in pharmaceutical clinical drug development.

• Strong preference for candidates with a proven history of improving clinical trial processes.

• Experience in industry or academia in late-phase drug development for Oncology.

• Excellent communication and presentation skills to effectively convey scientific concepts and data to leadership committees both internally and externally (both written and verbal).

• Proficient in designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements.

• Knowledgeable in conducting study data readout activities, including data cleaning, database locking, data extraction, and producing data outputs.

• Experience in drafting high-level submission documents for regulatory submissions, including authoring clinical regulatory responses for health regulatory interactions.

• Contributed as an author to scientific publications and data presentations at scientific conferences.

• Familiarity with clinical data analysis tools such as Spotfire or other data analysis software.

🏝️ Benefits

• 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.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models, including remote and hybrid work arrangements where feasible.