[Hiring] Director, Clinical Technical Operations @Otsuka Pharmaceutical Co., Ltd.

Role Description

The Director, Clinical Technical Operations provides leadership and oversight for the technology ecosystem that supports global clinical trial programs. This role is responsible for executing the Clinical Management technology strategy, ensuring that clinical systems, digital processes, data governance frameworks, and technology-enabled capabilities effectively support the planning, execution, oversight, and inspection readiness of clinical trials.

The Director serves as a key business partner across applicable internal business functions and external service providers. The role leads operational excellence, technology transformation, and data-driven decision-making through the implementation and optimization of clinical technologies, integrated platforms, automation solutions, and clinical operational data initiatives. In addition to technology leadership responsibilities, the role provides expertise and guidance in clinical trial operations to ensure technology investments effectively support study planning, execution, quality oversight, risk management, and successful delivery of clinical development programs.

This individual leads a team of Clinical Technical Operations professionals and contributes to strategic vendor relationships, technology roadmaps, governance committees, and cross-functional initiatives to ensure compliant, scalable, and effective clinical operations capabilities.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, Public Health, Information Systems, or related discipline.
• Minimum 12+ years of experience within pharmaceutical, biotechnology, or CRO environments supporting clinical operations.
• Minimum 10+ years of leadership experience managing teams, programs, or complex cross-functional initiatives.
• Extensive experience with clinical trial technologies and digital platforms, including CTMS, eTMF, EDC, IRT, eCOA/ePRO, and related systems.
• Demonstrated expertise in end-to-end clinical trial operations, including study start-up, site activation, enrollment management, monitoring oversight, study closeout, and inspection readiness.
• Strong understanding of Clinical Operations functional processes, metrics, and operational risk management methodologies.
• Experience utilizing clinical operational metrics, key risk indicators (KRIs), and performance dashboards to drive decision-making and oversight.
• Working knowledge of clinical development processes across Phase I–IV studies and global clinical trial execution models and regulations.
• Strong understanding of inspection readiness expectations and quality management principles.
• Demonstrated success leading technology implementation, digital transformation, and process improvement initiatives at an organizational level.
• Experience with system integration strategies, operational data governance, and enterprise architecture concepts.
• Demonstrated experience overseeing CROs, clinical vendors, and strategic service providers in a regulated clinical development environment.
• Proven ability to influence senior stakeholders and drive cross-functional alignment.
• Excellent leadership, communication, project management, and strategic planning skills.
• Proficiency in Microsoft Office applications and business intelligence/reporting tools.
• Willingness to travel as needed.

Requirements

• Advanced degree (MS, MBA, MPH, or equivalent) preferred.
• Prior experience in Clinical Operations leadership, Study Management, Clinical Program Management, or Clinical Trial Management preferred.
• Experience supporting hybrid and technology-enabled clinical trial models preferred.
• Experience developing clinical operations performance frameworks and portfolio-level operational reporting preferred.
• Experience supporting complex global clinical development programs preferred.
• Experience with enterprise data governance, business intelligence, analytics platforms, and automation technologies preferred.
• Experience leading organizational change management initiatives and large-scale technology deployments preferred.
• Relevant certifications in project management, clinical research, information systems, or quality management preferred.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.