Director, Global Clinical Program Management

Otsuka America Pharmaceutical Inc.; Trenton (NJ); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision coverage

401(k) plan with match

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. The role collaborates with the Senior Director and ensures programs meet ICH/GCP standards and regulatory requirements.

The position involves leading cross-functional teams, coordinating with ESPs, and contributing to budget and timelines while maintaining the highest scientific quality across studies.

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs and GCP/ICH.
• Experience with CROs, outsourcing and vendor SOW evaluation.
• Strong understanding of regulatory requirements and data management.
• Excellent communication, planning, analytical and leadership skills.
• Proficiency with MS Office and clinical trial software.

Responsibilities

• Oversee operational strategy and management of global clinical programs.
• Coordinate with internal departments and ESPs for program execution.
• Develop and defend clinical program documents and regulatory submissions.
• Lead program-level meetings and alliance governance.
• Ensure inspection readiness and risk mitigation at program level.

Skills

Clinical ops

GCP/ICH regs

Drug development

Regulatory compliance

Leadership

Data management

Biostatistics

Project coordination

Education

Bachelor’s degree + 10+ years CTM

Advanced degree (preferred)

Tools

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. The role collaborates with the Senior Director and ensures programs meet ICH/GCP standards and regulatory requirements.

The position involves leading cross-functional teams, coordinating with ESPs, and contributing to budget and timelines while maintaining the highest scientific quality across studies.