Director, Clinical Strategy & Operations

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director to lead the operational strategy and management of clinical programs, coordinating with internal teams and external providers. The role involves planning, execution, and completion of programs under regulatory guidance and within timelines and budget.

You will drive development of regulatory documents, trial reports, and HEOR considerations, while guiding teams and ensuring inspection readiness and risk mitigation across programs.

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs, GCP/ICH.
• Thorough knowledge of CROs, outsourcing, and evaluation of SOW.
• Advanced understanding of drug development principles and trial management.
• Strong regulatory knowledge and biostatistics, data management, and medical writing.
• Strong communication, organization, planning, analytical and people management skills.
• Proficient with Word, Excel, PowerPoint, Outlook; travel up to 25%.

Responsibilities

• Provide scientific clinical research and operational expertise for GCDP strategy and objectives.
• Represent Clinical Management in development of timelines and budget for opportunities.
• Ensure program standards (CRFs, outsourcing specs, templates) across studies.
• Contribute to clinical trial reports, publications, and presentations.
• Develop program-level financial estimates and MLTP contributions.
• Lead program teams as Co-Chair or lead clinical management representative for meetings.

Skills

Clinical Operations

Drug Development

GCP/ICH

Regulatory Compliance

Leadership

Planning

Data Analysis

People Management

Education

Bachelor's Degree with 14+ years pharma experience

Tools

Microsoft Office

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Director to lead the operational strategy and management of clinical programs, coordinating with internal teams and external providers. The role involves planning, execution, and completion of programs under regulatory guidance and within timelines and budget.

You will drive development of regulatory documents, trial reports, and HEOR considerations, while guiding teams and ensuring inspection readiness and risk mitigation across programs.