Director of Global Clinical Programs & Operations (Remote)

Otsuka America Pharmaceutical Inc.; Helena (MT); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee the operational strategy of global clinical programs. The role requires coordinating with senior leadership, ESPs, and internal departments to ensure research activities align with ICH/GCP guidelines, timelines, and budget.

The Director provides program-level leadership, supports development of regulatory documents, and ensures consistency across studies. Travel up to 25% is anticipated.

Qualifications

• Comprehensive knowledge of clinical operations, drug development process, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of SOW.
• Advanced understanding of drug development and clinical trial management.
• Strong knowledge of global regulatory requirements, biostatistics, data management, and medical writing.
• Strong communication, organization, planning, analytical, problem solving, and people management skills.
• Ability to travel up to 25%.

Responsibilities

• Provides scientific clinical research and operational expertise in development of overall GCDP strategy and objectives.
• Represents Clinical Management in development of Clinical Development Plan, timelines, and budget for business opportunities.
• Ensures program standards (CRFs, outsourcing specs, templates) are applied across studies for dossier consistency.
• Contributes to final analyses and development of clinical trial reports and publications.
• Leads program-level teams as Co-Chair or lead clinical management representative for meetings.

Skills

Clinical operations

GCP/ICH compliance

Regulatory strategy

Vendor management

Biostatistics & data mgmt

Medical writing

Cross-functional leadership

Travel up to 25%

Education

Bachelor’s degree + 10y CTM

Tools

eCRFs

IRT

CTMS

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee the operational strategy of global clinical programs. The role requires coordinating with senior leadership, ESPs, and internal departments to ensure research activities align with ICH/GCP guidelines, timelines, and budget.

The Director provides program-level leadership, supports development of regulatory documents, and ensures consistency across studies. Travel up to 25% is anticipated.