Senior Director, Clinical Trials Management

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

The Senior Director, Clinical Trials Management is responsible for operational leadership and oversight for clinical programs including operational strategy, clinical trial conduct, project planning, budget management, timelines, resource management, site management, monitoring, study management, vendor management, and project operational support. Drives all aspects of study execution in collaboration with cross-functional teams and vendors.  Has the ability to offer strategic direction for clinical trials activities primarily in the US, Japan and Europe and other world areas as assigned, to ensure timely completion of department goals and objectives with minimum supervision. Represents clinical trial management on program steering committees and other committees as required.

Job Duties and Responsibilities

• Responsible for directing the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within a program(s), ensuring adherence to timelines, budgets, and quality standards
• Develop and oversee the proliferation of study documents and plans to ensure adequate controls, aligning with GCP and regulatory requirements for study conduct. They will provide expert input into study protocols, informed consents, clinical study reports, and other clinical documents, as appropriate for assigned studies.
• Develop and oversee the set-up, maintenance, and completeness of the Trial Master File (TMF) for inspection readiness. They may review trial data to ensure completeness and accuracy of data and reporting in collaboration with other relevant functions. In collaboration with Clinical Operations Study Lead (as applicable), cross-functional teams and vendors on quality and compliance activities, ensuring continuous improvement in study conduct, proactively identifying and mitigating risks/issues to the study to ensure successful study conduct and reporting of study data. 
• Develop, manage, and refine budgets, forecasts, and reporting, for the assigned program, collaborating with relevant stakeholders to ensure financial oversight and control
• Serve as the functional representative on cross-functional teams related to the assigned program, facilitating effective communication and collaboration among various departments
• Assume a proactive role in cross-functional initiatives, potentially leading or contributing as a subject matter expert, ensuring that clinical operations considerations are integrated effectively
• Provide subject matter expertise on department initiatives, workstreams, and process improvement efforts, contributing to the continuous enhancement of clinical operations processes and procedure, as necessary
• Contribute to the development and refinement of organizational policies, procedures, and resourcing strategies related to clinical operations activities.
• Provide oversight in the selection, training, and management of study personnel, Contract Research Organizations (CROs), and other vendors, ensuring they meet project requirements and objectives of the assigned program
• Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities
• Collaborate closely with the Clinical Operations leadership team, potentially serving as a member of the team to share insights, contribute to strategic decisions, and align program-level activities wit