Director, Clinical Programs & Strategy

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. in Lincoln, Nebraska, seeks a Director of Clinical Management to lead operational strategy for global clinical programs, coordinating with Otsuka departments and external service providers.

You will plan, execute, and monitor clinical programs per GCP, ICH, and regulatory guidance, manage budgets and timelines, and guide cross-functional teams to ensure high-quality clinical dossiers and submissions.

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs, and GCP/ICH.
• Thorough knowledge of CROs, outsourcing, and evaluation of vendor SOW.
• Advanced understanding of drug development principles 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.
• Strong computer skills with Microsoft Office; familiarity with clinical trial software (eCRFs, IRT, CTMS).
• Ability 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 opportunities.
• Ensure program standards (CRFs, outsourcing specs, templates) are applied consistently across studies.
• Contribute to final analyses, trial reports, publications, and presentations.
• Develop program-level financial estimates and MLTP contributions.
• Lead program teams as Co-Chair or lead representative for meetings.
• Assist in regulatory submissions and health authority briefing books.

Skills

Clinical operations

Drug development

GCP/ICH regulations

Regulatory compliance

Biostatistics

Data management

Medical writing

Communication

Project management

Travel readiness

SOPs

Vendor management

Education

Bachelor’s degree in life sciences or related field

Advanced degree (MS/PhD) preferred

Tools

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. in Lincoln, Nebraska, seeks a Director of Clinical Management to lead operational strategy for global clinical programs, coordinating with Otsuka departments and external service providers.

You will plan, execute, and monitor clinical programs per GCP, ICH, and regulatory guidance, manage budgets and timelines, and guide cross-functional teams to ensure high-quality clinical dossiers and submissions.