Job Details
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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=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 manage multiple tasks simultaneously.
+ Demonstrated ability to influence through collaboration.
+ Flexibility to accommodate changes in priorities and project needs.
**Education and Experience**
+ Minimum of 5-8 years clinical research experience in the pharmaceutical/biotech industry or academic institution (clinical science, clinical operations, medical writing, clinical site staff, etc.).
+ Prior hematologic malignancy experience strongly preferred.
+ BS/MS/PhD in a related life science discipline.
The base salary range for this role is $144,240 to $180,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
**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 manage multiple tasks simultaneously.
+ Demonstrated ability to influence through collaboration.
+ Flexibility to accommodate changes in priorities and project needs.
**Education and Experience**
+ Minimum of 5-8 years clinical research experience in the pharmaceutical/biotech industry or academic institution (clinical science, clinical operations, medical writing, clinical site staff, etc.).
+ Prior hematologic malignancy experience strongly preferred.
+ BS/MS/PhD in a related life science discipline.
The base salary range for this role is $144,240 to $180,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Job #NLX276459688