Sumitomo Pharma America, Inc. · 1 day ago
Sr Clinical Research Scientist
United States
Full-time
Remote
Senior Level
$144K/yr - $180K/yr
5+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health sectors. The Clinical Scientist role involves contributing to the development and execution of clinical strategies for oncology programs, collaborating closely with the Clinical Research Team to design, implement, and analyze clinical studies.
Pharmaceuticals
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
Qualification
Required
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
Preferred
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
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
Sumitomo Pharma America, Inc.
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.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase