Clinical Research Scientist

US-Remote

Full time

R01455

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

This position reports to Director, Clinical Research Scientist and is part of Clinical Development, which designs and executes clinical programs to evaluate the safety, efficacy, and value of investigational therapies. This is an exciting opportunity to contribute to the development and execution of clinical research programs in oncology while building clinical development expertise. Through extensive interaction with the Clinical Research Team, this role will support the planning, conduct, analysis, and reporting of clinical studies in collaboration with cross functional teams including clinical operations, data management, statistics, programming, translational research, etc.

• Support the Clinical Research Team in the planning, execution, and monitoring of clinical studies.

• Assist with protocol compliance review, including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, and key safety and efficacy measures.

• Support review and documentation of protocol deviations in collaboration with the Clinical Research Team.

• Assist with ongoing review of subject-level clinical data and contribute to identification of data trends and potential issues.

• Collaborate with cross-functional team members to support review, analysis, and interpretation of clinical study results.

• Assist with the preparation of study-related documents including protocols, informed consent forms, clinical study reports, study presentations, and other clinical documents.

• Support database lock activities, data review efforts, and preparation of study deliverables.

• Assist in the preparation of scientific publications, abstracts, posters, and presentations.

• Support investigator meetings, advisory boards, and other scientific meetings through meeting preparation, material development, and documentation.

• Maintain awareness of developments in oncology, clinical research methodologies, and regulatory requirements.

• Conduct literature reviews and summarize scientific and clinical information relevant to study objectives and disease areas.

• Perform other duties as assigned.

• Basic understanding of the clinical drug development process and clinical trial conduct.

• Interest in oncology drug development; prior oncology experience is preferred but not required.

• Foundational knowledge of GCP, clinical research regulations, and clinical study methodology.

• Ability to review and interpret clinical data with guidance from senior team members.

• Strong analytical, organizational, and problem-solving skills.

• Effective written and verbal communication skills.

• Proficiency with Microsoft Word, Excel, PowerPoint, and related software applications.

• Strong attention to detail and ability to maintain high-quality work.

• Ability to work collaboratively in a cross-functional team environment.

• Demonstrated ability to manage multiple assignments and prioritize effectively.

• Eagerness to learn and develop clinical research and scientific expertise.

• Flexibility and adaptability in a fast-paced environment.

• BS/MS/PhD in a related life science discipline…