Director, Clinical Operations & Strategy

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director to lead the operational strategy for global clinical programs.

In collaboration with the Senior Director, you will oversee planning, execution, and completion of clinical programs in compliance with ICH, GCP, and SOPs, within time and budget constraints. You will guide development of the Global Clinical Development Plan, manage cross-functional teams, and ensure standardized study materials and regulatory readiness while contributing to

Qualifications

• Comprehensive knowledge of clinical operations, drug development processes, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and vendor SOW evaluation.
• Advanced understanding of drug development principles and clinical trial management.
• Strong regulatory knowledge, biostatistics, data management, and medical writing.
• Excellent communication, organization, planning, and people management skills.

Responsibilities

• Provide scientific clinical research and operational expertise for the Global Clinical Development Plan.
• Lead program level teams and represent Clinical Management in budget and timelines discussions.
• Ensure standardization across studies (CRFs, outsourcing specs, training) for consistent clinical dossiers.
• Contribute to analyses, trial reports, publications, and presentations.
• Develop program-level financial estimates and contribute to MLTP.
• Oversee regulatory document development and inspection readiness programs.

Skills

Clinical operations

Drug development

GCP/ICH regulations

Regulatory compliance

Communication and leadership

Education

Bachelor’s Degree with pharma industry experience

10 years clinical trial management experience

Advanced degree (preferred)

Tools

Microsoft Word

Excel

PowerPoint

Outlook

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Director to lead the operational strategy for global clinical programs.

In collaboration with the Senior Director, you will oversee planning, execution, and completion of clinical programs in compliance with ICH, GCP, and SOPs, within time and budget constraints. You will guide development of the Global Clinical Development Plan, manage cross-functional teams, and ensure standardized study materials and regulatory readiness while contributing to