Director, Global Clinical Programs & Strategy

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

Benefits offered by this job

Comprehensive medical

Dental & Vision

401(k) match

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy and management of clinical programs, ensuring adherence to ICH, GCP, and internal SOPs.

You will collaborate with ESPs, cross-functional teams, and senior leadership to plan, execute, and complete programs on time and within budget. The role requires extensive experience in clinical development, program leadership, and regulatory submissions, with travel up to 25%.

Qualifications

• Comprehensive knowledge of clinical operations, drug development, SOPs, GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and vendor SOW evaluation.
• Advanced understanding of drug development and trial management.
• Strong regulatory, biostatistics, data management and medical writing know-how.
• Excellent communication, organization and leadership abilities.

Responsibilities

• Provide scientific clinical research and operational expertise for the Global Clinical Development Plan.
• Coordinate with ESPs and other departments for program execution and budget.
• Ensure standards across studies for consistent clinical dossiers (CRFs, templates, etc.).
• Lead program-level teams as Co-Chair or lead clinical management representative.
• Develop regulatory documents (IB/IMPD/IND/CTAs) and support labeling teams.
• Draft HEOR strategy and engage with Medical Affairs for information requests.

Skills

Clinical operations

GCP/ICH & regulations

Budget & forecasting

Leadership & people management

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s Degree in life sciences/pharm

Advanced degree preferred

Tools

eCRFs

CTMS

IRTs

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy and management of clinical programs, ensuring adherence to ICH, GCP, and internal SOPs.

You will collaborate with ESPs, cross-functional teams, and senior leadership to plan, execute, and complete programs on time and within budget. The role requires extensive experience in clinical development, program leadership, and regulatory submissions, with travel up to 25%.