Director, Clinical Programs & Strategy

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead operational strategy for global clinical programs in the United States.

In collaboration with the Senior Director, you will plan, execute, and oversee clinical studies in compliance with GCP, ICH, and company SOPs, managing timelines and budgets while coordinating with ESPs and internal partners. You will chair program-level teams, develop regulatory submissions, and shape HEOR strategies, ensuring data quality,

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of vendor SOWs.
• Advanced understanding of drug development principles and trial implementation and management.
• Strong knowledge of global regulatory requirements, biostatistics, data management, and medical writing.

Responsibilities

• Provides scientific clinical research and operational expertise for the Global Clinical Development Plan.
• May represent Clinical Management in timelines, budgets for Business Development opportunities.
• Ensures program standards (CRFs, outsourcing specs, slides, templates) are consistently applied.
• Contributes to the final analysis and interpretation including clinical trial reports and publications.
• Develops program-level financial estimates and MLTP contributions.
• Leads program-level teams as Co-Chair and/or lead for meetings (CRT/GBT/PDC/JDC/Alliance).
• Prepares regulatory documents (IB/IMPD, IND/CTA annual reports) and supports labeling teams.
• Leads development of clinical sections of regulatory documents and inspection readiness programs.

Skills

Clinical operations

GCP/ICH compliance

Regulatory knowledge

Vendor management

Team leadership

Travel readiness

Education

Bachelor’s Degree in Life Sciences

Tools

Microsoft Office

eCRFs/IRT/CTMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead operational strategy for global clinical programs in the United States.

In collaboration with the Senior Director, you will plan, execute, and oversee clinical studies in compliance with GCP, ICH, and company SOPs, managing timelines and budgets while coordinating with ESPs and internal partners. You will chair program-level teams, develop regulatory submissions, and shape HEOR strategies, ensuring data quality,