Director of Global Clinical Programs & Strategy

Otsuka Pharmaceutical Co., Ltd; United States; On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Tuition reimbursement

Paid holidays and leave

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with ESPs and internal departments to ensure studies align with ICH/GCP, timelines and budgets.

The role requires leading program-level teams, contributing to regulatory submissions, and ensuring high-quality clinical documentation while advancing HEOR strategy where needed.

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and SOW evaluation.
• Advanced understanding of drug development and trial management.
• Strong regulatory knowledge, biostatistics, data management, and medical writing.
• Excellent communication, organization, planning, analytical, and leadership skills.
• Proficient with MS Office and trial software (eCRFs, IRT, CTMS).
• Willingness to travel up to 25%.

Responsibilities

• Provide scientific clinical research and operational expertise for the Global Clinical Development Plan.
• Represent Clinical Management in development of timelines and budgets for BD opportunities.
• Ensure standards are applied across studies for consistent clinical dossiers.
• Contribute to clinical trial reports, publications, and presentations.
• Develop program level financial estimates and MLTP contributions.
• Lead program teams as Co-Chair and/or lead clinical management representative for meetings.
• Prepare regulatory documents and maintain filings with Health Authorities.
• Lead development of regulatory sections and inspection readiness programs.

Skills

Clinical operations

GCP/ICH regulations

CROs & SOW evaluation

Regulatory knowledge

Biostatistics & data management

Medical writing

Leadership & people management

Communication & collaboration

Education

Bachelor’s degree + 10 years CTM experience

Supervisor experience

Advanced degree (preferred)

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

eCRFs/IRT/CTMS proficiency

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with ESPs and internal departments to ensure studies align with ICH/GCP, timelines and budgets.

The role requires leading program-level teams, contributing to regulatory submissions, and ensuring high-quality clinical documentation while advancing HEOR strategy where needed.