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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. Essential Functions Required for Job Direct 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. Oversee the development and control of key study documents and plans (e.g., protocols, informed consents, clinical study reports), ensuring alignment with GCP and regulatory requirements. Oversee Trial Master File (TMF) set-up, maintenance, and completeness to ensure inspection readiness; collaborate with relevant functions to support data completeness and accurate reporting. Proactively identify, manage, and mitigate study/program risks and issues; lead quality and compliance activities with cross-functional teams and vendors to drive continuous improvement. Develop, manage, and refine budgets, forecasts, and financial reporting for the assigned program(s), ensuring appropriate oversight and control. Serve as the clinical operations' functional representative on cross-functional program teams; facilitate effective communication and collaboration across departments and with external partners. Provide subject matter expertise for departmental initiatives and process improvement efforts; contribute to the development and refinement of clinical operations policies, procedures, and resourcing strategies. Provide oversight in the selection, onboarding, training, and performance management of study personnel, CROs, and other vendors to ensure delivery against contracts, expectations, and program objectives. Manage direct reports (as applicable) through coaching, mentorship, and performance feedback; collaborate with Clinical Operations leadership to align program-level activities with departmental goals and strategy. Knowledge, Skills and Abilities (general & technical): Implement clinical development principles and industry standards, including GCP and ICH guidelines. Understands drug development and the end-to-end clinical trial lifecycle (protocol/feasibility through close-out and reporting). Experience as a clinical operations lead. Interprets applicable regulations and literature and stays current on evolving GCP/ICH expectations and inspection readiness. Communicates effectively with internal stakeholders, sites, vendors, and consultants, including translating scientific/medical concepts. Produces clear documentation (e.g., reports and procedures) and presents information effectively to groups. Solves problems and makes decisions in situations with limited standardization and multiple variables. Strong cross-functional collaboration across diverse, global teams and leads through influence/coaching in a management role. Manages multiple vendors/contractors and coordinates partners to deliver study objectives. Prioritizes and delivers across competing timelines; manages time and multiple tasks. Demonstrates organizational awareness and connects interdependencies to maintain the broader program perspective. Education & Experience Requirements: Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field. Minimum 10-15 years (without Master's) or 8-12 years (with Master's) of relevant experience in biotech/pharmaceutical or CRO setting, with experience supporting Phases 1-4 clinical studies.
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