Clinical Trials Management Director

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.

Preferred Qualifications:

• Experience managing global patient population studies.
• Therapeutic experience working with stem cells and regenerative medicine.
• Strong phase1/2 experience.

Travel Requirements:

Primarily remote role with peri