Director, Global Clinical Programs & Strategy

Otsuka America Pharmaceutical Inc.; Boise (ID); 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. is seeking a Director of Clinical Management to oversee the operational strategy and management of clinical programs in collaboration with the Senior Director.

You will plan, execute, and complete programs in line with GCP, ICH, and Otsuka SOPs within agreed timelines and budgets. You will coordinate with ESPs and other departments, guide program-level risk mitigation, and drive standardization across studies while developing regulatory submissions and HEOR

Qualifications

• Comprehensive knowledge of clinical operations, drug development process, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of vendor SOWs.
• Advanced understanding of drug development principles and clinical trial implementation and 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 and clinical trial software (eCRFs, IRT, CTMS).

Responsibilities

• Provides scientific clinical research and operational expertise in the development of the Global Clinical Development Plan.
• Represents Clinical Management in development of timelines and budget for opportunities.
• Ensures standardization across studies for CRFs, outsourcing specs, training and templates.
• Contributes to clinical trial reports, publications, and internal/external presentations.
• Develops program level financial estimates and MLTP contributions.
• Leads program level teams as Co-Chair and/or lead clinical management representative for meetings.

Skills

Clinical operations

Drug development

GCP/ICH compliance

CRO management

Regulatory knowledge

Biostatistics

Data management

Medical writing

Leadership

Project planning

Communication

Education

Bachelor’s Degree in life sciences or related field

Advanced degree

Tools

eCRFs

CTMS

IRT

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee the operational strategy and management of clinical programs in collaboration with the Senior Director.

You will plan, execute, and complete programs in line with GCP, ICH, and Otsuka SOPs within agreed timelines and budgets. You will coordinate with ESPs and other departments, guide program-level risk mitigation, and drive standardization across studies while developing regulatory submissions and HEOR