Director, Global Clinical Programs & Operations

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Tuition reimbursement

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director to lead the operational strategy and management of global clinical programs in collaboration with the Senior Director of Clinical Management.

Responsibilities include planning, executing, and completing programs per GCP/ICH, with cross-functional coordination across ESPs, regulatory, and medical affairs. The role requires strategic leadership, budgeting, and ensuring regulatory readiness and high-quality clinical documentation.

Qualifications

• Extensive knowledge of clinical operations and GCP/ICH regulations.
• Experience with CROs, outsourcing, and evaluating vendor SOWs.
• Strong understanding of drug development and trial management.
• Regulatory, biostatistics, data management and medical writing expertise.
• Proven leadership and strategic thinking in cross-functional teams.

Responsibilities

• Oversee operational strategy and management of clinical programs.
• Coordinate with ESPs, other departments, and senior management.
• Develop clinical development plans, timelines, and budgets.
• Ensure SOPs, CRFs, and templates are standardized across studies.
• Lead program-level teams as Co-Chair or lead clinical management rep.
• Prepare regulatory submissions and briefing books; support inspections.

Skills

Clinical operations

GCP/ICH compliance

Vendor management

Drug development

Regulatory knowledge

Biostatistics

Data management

Medical writing

Leadership

Communication

Education

Bachelor's degree in pharmaceutical/related field

Advanced degree (preferred)

Tools

Microsoft Office

eCRFs

CTMS

IRT

Job description

Otsuka America Pharmaceutical Inc. seeks a Director to lead the operational strategy and management of global clinical programs in collaboration with the Senior Director of Clinical Management.

Responsibilities include planning, executing, and completing programs per GCP/ICH, with cross-functional coordination across ESPs, regulatory, and medical affairs. The role requires strategic leadership, budgeting, and ensuring regulatory readiness and high-quality clinical documentation.