Sumitomo Pharma
Overview
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 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 Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Clinical Project Manager. Responsible for assisting the Clinical Project Manager (CPM) with the planning, implementation, execution, and management of multiple clinical studies by supporting the CPM in overseeing day-to-day operations and assisting as needed with the management of outside Clinical Research Organizations. Responsibilities
Supports the CPM to design, develop, and deliver the clinical study per agreed upon timelines. Assists in planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data. Monitors the status of clinical data collection of assigned clinical trials. Assists with preparation of potential investigator site lists and assists with their evaluation for inclusion in the study. Prepares and reviews study-related plans and documents when required. Reviews study-related plans generated by CROs and vendors, ensuring documents are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies. Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required. Participates in meetings such as Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training. Prepares and delivers program/study updates as determined by the project team. Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members. Supports CPM with review of change orders from CROs, vendors and investigator sites (as applicable). Provides input into contracts, work orders and/or change orders. Assists with review and management of invoice tracking/reconciliation. Anticipates potential study issues and prepares contingency plans in consultation with the CPM. Supports the CPM to ensure assigned studies adhere to all applicable regulations and requirements. Establishes collaborative and productive relationships with parent company, internal/external partners and relevant affiliates. Identifies issues found in clinical studies, communication and oversight of CROs and vendors, and suggests/implements solutions and mitigations in consultation with the CPM. Participates in the preparation, review, updating and training of SOPs. Maintains knowledge of oncology therapeutic area, current medical practice, and pharmaceutical regulations to ensure best practice across activities. May mentor other junior team members. Performs other duties as requested. Key Core Competencies
Excellent written and oral communication skills. Demonstrated skills working within a matrix environment. Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in the parent company in Japan. Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance. Strong attention to detail and the ability to establish priorities, schedule and meet deadlines. Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems. Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas. Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards. Strong analytical skills with a data-driven approach to planning, executing, and problem solving. Working knowledge of current global regulatory requirements and guidelines for clinical trials. Education and Experience
B.A. or B.S./M.S./Ph.D. in a related life science discipline is preferred. Minimum of 3-5 years of industry experience in clinical drug development or equivalent academic experience in clinical trials. The base salary range for this role is $104,600 to $130,800. Base salary is part of our total rewards package which includes merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves. Our 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 will depend on candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not to be construed as an exhaustive list of responsibilities. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with best industry practices and the highest ethical standards. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to protected characteristics as defined by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website: https://www.us.sumitomo-pharma.com
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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 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 Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Clinical Project Manager. Responsible for assisting the Clinical Project Manager (CPM) with the planning, implementation, execution, and management of multiple clinical studies by supporting the CPM in overseeing day-to-day operations and assisting as needed with the management of outside Clinical Research Organizations. Responsibilities
Supports the CPM to design, develop, and deliver the clinical study per agreed upon timelines. Assists in planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data. Monitors the status of clinical data collection of assigned clinical trials. Assists with preparation of potential investigator site lists and assists with their evaluation for inclusion in the study. Prepares and reviews study-related plans and documents when required. Reviews study-related plans generated by CROs and vendors, ensuring documents are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies. Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required. Participates in meetings such as Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training. Prepares and delivers program/study updates as determined by the project team. Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members. Supports CPM with review of change orders from CROs, vendors and investigator sites (as applicable). Provides input into contracts, work orders and/or change orders. Assists with review and management of invoice tracking/reconciliation. Anticipates potential study issues and prepares contingency plans in consultation with the CPM. Supports the CPM to ensure assigned studies adhere to all applicable regulations and requirements. Establishes collaborative and productive relationships with parent company, internal/external partners and relevant affiliates. Identifies issues found in clinical studies, communication and oversight of CROs and vendors, and suggests/implements solutions and mitigations in consultation with the CPM. Participates in the preparation, review, updating and training of SOPs. Maintains knowledge of oncology therapeutic area, current medical practice, and pharmaceutical regulations to ensure best practice across activities. May mentor other junior team members. Performs other duties as requested. Key Core Competencies
Excellent written and oral communication skills. Demonstrated skills working within a matrix environment. Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in the parent company in Japan. Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance. Strong attention to detail and the ability to establish priorities, schedule and meet deadlines. Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems. Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas. Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards. Strong analytical skills with a data-driven approach to planning, executing, and problem solving. Working knowledge of current global regulatory requirements and guidelines for clinical trials. Education and Experience
B.A. or B.S./M.S./Ph.D. in a related life science discipline is preferred. Minimum of 3-5 years of industry experience in clinical drug development or equivalent academic experience in clinical trials. The base salary range for this role is $104,600 to $130,800. Base salary is part of our total rewards package which includes merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves. Our 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 will depend on candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not to be construed as an exhaustive list of responsibilities. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compliance: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with best industry practices and the highest ethical standards. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to protected characteristics as defined by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website: https://www.us.sumitomo-pharma.com
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