Senior Director, Clinical Operations

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational 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 Operations is a member of the Clinical Operations leadership team, responsible for Risk-Based Quality Management, Operational Data & Analytics, Records Management and Inspection Readiness Strategies across all clinical studies in Phase 1-4. This individual provides strategic direction on all aspects of study monitoring and oversight for clinical studies within Clinical Operations which also includes implementing fit-for-purpose solutions, systems and processes. The ideal candidate will be knowledgeable for all aspects of clinical trials operations, Good Clinical Practice (GCP), and relevant regulatory guidelines.

Job Duties and Responsibilities

• Ensure monitoring across all studies is conducted in alignment with regulatory requirements, leverages risk-based quality management methods and SMPA best practices

• In collaboration with relevant functions, define and implement risk-based monitoring strategies including risk assessment methods, fit for purpose monitoring models, data analytics and centralized monitoring methods

• Define and implement targeted strategies for oversight of CRO monitoring practices and serve as an escalation resource for study teams to ensure effective strategies/methods are in place

• Maintain expert proficiency in systems and technology as applicable to central monitoring analytics, operational data collection, reporting, and access.  Where possible, advise, implement and contribute to the design of novel systems in alignment with department and company data strategy/objectives.

• Lead or contribute as the subject matter expert on department and cross-functional initiatives, workstreams, and process improvement efforts; contributing to the continuous enhancement to the clinical operations processes and ensuring clinical operations considerations are integrated effectively

• Lead and/or oversee development and maintenance of relevant department SOPs, best practices, tools, and templates

• Assist stakeholder teams with development and maintenance of relevant inspection-readiness processes and materials.  May serve as a Clinical Operations representative for audits and regulatory inspections.

• Lead and provide oversight of the Clinical Records Management (Trial Master File) team

• Develop and/or review budgets for clinical operations department and assigned vendor budgets

• Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities

Key Core Competencies

• Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP and ICH-Guidelines

• Advanced proficiency in clinical operations monitoring and oversight, CRO-specific monitoring processes and working with leading CROs

• Visionary in risk-based quality management, analytics and graphical visualizations as it pertains to clinical trial operational performance and/or clinical trial critical data compliance and quality

• Experienced in systems/technology implementation and maintenance as it supports Clinical Operations, in particular, eTMF and Operational Data Modeling systems

• Strong cross-functional communication with global partnerships, executive leadership, business/operational and technical colleagues with a solid awaren