Global Head, Clinical Technology & Operations

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Director, Clinical Technical Operations to lead the technology ecosystem powering global clinical trials. You will drive strategy, oversee CTMS/eTMF/EDC platforms, and ensure data governance, RBQM, and inspection readiness across programs.

You will partner with Clinical Operations and external vendors to optimize study planning, execution, and quality while enabling scalable, compliant operations and data-driven decisions.

Qualifications

• Required Bachelor’s degree in Life Sciences, Clinical Research, Nursing, Pharmacy, Public Health, Information Systems, or related discipline.
• Minimum 12+ years in pharmaceutical/biotech/CRO environments supporting clinical operations.
• Minimum 10+ years of leadership experience managing teams, programs, or cross-functional initiatives.
• Extensive experience with clinical trial technologies and digital platforms (CTMS, eTMF, EDC, IRT, eCOA/ePRO).
• Strong understanding of RBQM/RBM and data governance in a regulated environment.
• Experience overseeing CROs and external service providers in clinical development.

Responsibilities

• Lead Clinical Technology Strategy & Leadership to drive digital transformation and study execution.
• Oversee Clinical Systems & Platform governance, validation, and lifecycle management.
• Drive Data Governance, analytics, and enterprise data architecture for operational transparency.
• Partner with Clinical Operations to ensure compliant, efficient trial delivery across phases.
• Lead process optimization, automation, and technology-enabled quality improvements.
• Manage cross-functional teams and vendor relationships to align investments with program needs.
• Ensure inspection readiness, quality, and regulatory compliance across systems.

Skills

Leadership

Strategic thinking

Stakeholder mgmt

Data governance

Vendor mgmt

Cross-functional

Education

Bachelor's degree in Life Sciences/related

Advanced degree preferred (MS/MBA/MPH)

Tools

CTMS

eTMF

EDC

IRT

eCOA/ePRO

Job description

Otsuka Pharmaceutical Co., Ltd. seeks a Director, Clinical Technical Operations to lead the technology ecosystem powering global clinical trials. You will drive strategy, oversee CTMS/eTMF/EDC platforms, and ensure data governance, RBQM, and inspection readiness across programs.

You will partner with Clinical Operations and external vendors to optimize study planning, execution, and quality while enabling scalable, compliant operations and data-driven decisions.