Director, Clinical Technical Operations (Clinical Technology)

Location: Remote. The stated compensation range applies to individuals hired to perform the role in the United States.

Salary: $186,489–$278,875, plus incentive opportunity.

Company

Otsuka Pharmaceutical Companies develops pharmaceutical and healthcare solutions, with this role supporting global clinical development programs.

What you will do

• Lead the Clinical Technical Operations team and execute technology priorities aligned with Clinical Management objectives.
• Oversee the implementation, validation, optimization, integration, and lifecycle management of clinical systems, including CTMS, eTMF, EDC, IRT, eCOA/ePRO, study start-up, and analytics platforms.
• Establish data governance, stewardship, quality, security, retention, data-flow, and architecture standards for clinical operational data.
• Partner with Clinical Operations, IT, Data Management, Biostatistics, Quality Assurance, CROs, and vendors to improve trial execution, risk management, and inspection readiness.
• Drive workflow automation, process transformation, dashboards, KPIs, KRIs, predictive metrics, and executive reporting.
• Lead cross-functional technology implementations, change management, governance, investment recommendations, and remediation of audit findings and CAPAs.

Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, Nursing, Pharmacy, Public Health, Information Systems, or a related discipline.
• 12+ years of experience in pharmaceutical, biotechnology, or CRO environments supporting clinical operations.
• 10+ years of leadership experience managing teams, programs, or complex cross-functional initiatives.
• Extensive experience with clinical trial technologies, end-to-end trial operations, system integrations, operational data governance, and enterprise architecture.
• Strong knowledge of Phase I–IV clinical development, global trial execution, regulatory requirements, inspection readiness, quality management, RBQM, and RBM.
• Excellent leadership, communication, project management, strategic planning, stakeholder influence, and reporting skills; willingness to travel as needed.

Nice to have

• Advanced degree such as MS, MBA, MPH, or equivalent.
• Experience in Clinical Operations leadership, Study Management, Clinical Program Management, or Clinical Trial Management.
• Experience with hybrid and technology-enabled clinical trials, portfolio reporting, enterprise analytics, automation, organizational change, or large-scale technology deployments.
• Relevant certifications in project management, clinical research, information systems, or quality management.

Culture & Benefits

• Remote work environment supporting global clinical development programs.
• Medical, dental, vision, prescription drug, life, accidental death and dismemberment, and short- and long-term disability coverage.
• Tuition reimbursement, student loan assistance, 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Culture centered on accountability, strategic thinking, patient and customer focus, impactful communication, respectful collaboration, and professional development.