Senior Clinical Research Scientist

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Clinical Research Scientist. This is an exciting opportunity to be a key contributor to the development and execution of the clinical strategy for one or more oncology programs. Through extensive interaction with the Clinical Research Team, this role will have the opportunity to make strategic and scientific impact on current and future clinical programs, building clinical expertise to collaboratively design, plan, implement, analyze, and report clinical studies.  

Job Duties and 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.   

Key Core Competencies

• Comprehensive understanding of the drug development process from Phase 1 to Phase 3.
• Prior oncology drug development or oncology patient care experience preferred.
• 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 mana