Clinical Scientist Director – Late Development Oncology, Thoracic/GI

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

📋 Description

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

• Act as a vital team member in clinical development, offering hands-on oversight of protocol execution, medical data review, and ensuring clinical data quality to facilitate high-quality, decision-ready data.

• Collaborate effectively within cross-functional teams to ensure that clinical trials are conducted in accordance with the protocol intent, regulatory requirements, and Amgen’s quality standards.

• Serve as a clinical and scientific subject-matter expert for the designated therapeutic area and disease indication, with a strong emphasis on protocol execution and data integrity.

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

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

• Offer guidance and support in identifying and managing collaborators, consultants, and/or Clinical Research Organizations (CROs) for the successful completion of key projects.

• Collaborate cross-functionally to ensure clinical strategy is accurately translated into the development of the study concept document, study protocol, and associated documents.

• Ensure the integrity of protocols and components of clinical plans and oversee the delivery of the final protocol and its governance approval.

• Provide clinical insights into the implementation of clinical trials, delivery, clinical data review, and interpretation of results.

• Review and analyze clinical trial data to guarantee accuracy, completeness, and compliance with protocol and regulatory standards.

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

⛳️ Requirements

• Doctorate degree with 4 years of clinical development experience OR Master's degree with 7 years of clinical development experience OR Bachelor's degree with 9 years of clinical development experience.

• 5 years of experience in pharmaceutical clinical drug development.

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

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

• Excellent communication and presentation skills to effectively convey scientific concepts/data to leadership committees, both internally and externally (in written and oral forms).

• Experience in designing, monitoring, and implementing clinical trials for Oncology, as well as interpreting test results in compliance with Good Clinical Practice standards and regulatory guidelines.

• Knowledge of 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 interactions with health regulatory agencies.

• Act as a contributing author to scientific publications and present data at scientific conferences.

• Experience in clinical data analysis using tools such as Spotfire or other data analysis software.

🏝️ Benefits

• A comprehensive employee benefits package, which includes 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 where feasible.