Director, Global Clinical Program Management (Remote)

Otsuka America Pharmaceutical Inc.; Columbus (OH); Remote; USD 186,000 - 279,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director to lead the operational strategy and management of clinical programs in collaboration with senior leadership.

The role coordinates with internal teams, ESPs, and health authorities to plan, execute, and complete programs in line with GCP, ICH guidelines, and Otsuka SOPs. The position involves developing the Clinical Development Plan, budgets, training standards, and publishing clinical trial reports and publications while ensuring

Qualifications

• Comprehensive knowledge of clinical operations and regulatory guidelines.
• Experience managing CROs, outsourcing, and vendor SOWs.
• Deep understanding of drug development and clinical trial management.
• Familiarity with regulatory requirements, biostatistics, and medical writing.
• Strong communication, organization, and leadership abilities.
• Proficient with MS Office and trial management software.

Responsibilities

• Oversee operational strategy for global clinical programs and GCDP.
• Coordinate timelines, budgets, and collaboration with ESPs and internal teams.
• Lead program level teams as Co-Chair and manage meetings (CRT/GBT/PDC).
• Develop and defend regulatory documents and health authority submissions.
• Ensure data integrity, trial reports, publications, and presentations.
• Drive HEOR strategy and liaison with Medical Affairs for information requests.

Skills

Clinical operations

GCP/ICH regulations

Vendor/SOW evaluation

Drug development principles

Regulatory compliance

Communication & leadership

MS Office & CTMS

Travel up to 25%

Education

Bachelor’s Degree + 10+ years CTM exp

Advanced Degree (preferred)

Tools

MS Office

CTMS

eCRFs/IRT

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director to lead the operational strategy and management of clinical programs in collaboration with senior leadership.

The role coordinates with internal teams, ESPs, and health authorities to plan, execute, and complete programs in line with GCP, ICH guidelines, and Otsuka SOPs. The position involves developing the Clinical Development Plan, budgets, training standards, and publishing clinical trial reports and publications while ensuring