[Remote] Sr Clinical Research Scientist

Note: The job is a remote job and is open to candidates in USA. Sumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health areas. The Clinical Scientist role involves contributing to the clinical strategy for oncology programs, collaborating with the Clinical Research Team to design and implement clinical studies.

Responsibilities

• Contribute to and/or lead the design of clinical studies in close collaboration with the Clinical Research Team
• Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, and key safety and efficacy measures
• In collaboration with the Medical Lead, review protocol deviations to identify cause and appropriate resolution
• In collaboration with the Medical Lead, perform regular medical review of individual subject data
• Collaborate with the Clinical Research Team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
• Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
• In collaboration with the Clinical Research Team, contribute to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical documents
• Complete and/or lead other special projects
• Review and summarize relevant literature
• Contribute to drafting manuscripts and other publications and presentations
• Provide support for advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery of presentations
• Understand the competitive landscape and provide insights on strategic development pathways
• Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements
• As appropriate, coach and guide less experienced Clinical Scientists
• Proactively seek out and recommend process improvements
• Perform other duties as assigned

Skills

• Minimum of 5 years clinical research experience in the pharmaceutical/biotech industry or academic institution (clinical science, clinical operations, medical writing, clinical site staff, etc.)
• BS/MS/PhD in a related life science discipline
• Comprehensive understanding of the drug development process from Phase 1 to Phase 3
• Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Experience with interacting with medical monitors, development operations (clinical operations, data management, program management, regulatory affairs, medical writing) and clinical investigators
• Patient profile and data listing review experience
• Up to date in new clinical trial designs in oncology
• Strong analytical, problem-solving, and scientific writing skills
• Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills
• High level of organizational and project management skills
• Demonstrated ability to work independently in a matrix environment
• Demonstrated ability to prioritize and manage multiple tasks simultaneously
• Demonstrated ability to influence through collaboration
• Flexibility to accommodate changes in priorities and project needs
• Prior hematologic malignancy experience strongly preferred
• Prior oncology drug development or oncology patient care experience preferred

Benefits

• Merit-based salary increases
• Short incentive plan participation
• Eligibility for our 401(k) plan
• Medical, dental, vision, life and disability insurances
• Leaves provided in line with your work state
• Flexible paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

Company Overview

• Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS. It was founded in 2023, and is headquartered in Marlborough, Massachusetts, US, with a workforce of 1001-5000 employees. Its website is .

Company H1B Sponsorship

• Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships, with 8 in 2025, 9 in 2024, 14 in 2023. Please note that this does not guarantee sponsorship for this specific role.

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