Remote Director, Global Clinical Programs & Strategy

Otsuka America Pharmaceutical Inc.; Salem (OR); Remote; USD 120,000 - 160,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to lead operational strategy for global clinical programs in a remote, full-time capacity.

The role coordinates with internal departments, ESPs, and external partners to deliver trials on time and within budget. The Director will guide development plans, ensure compliance with GCP/ICH guidelines, and drive readiness for regulatory submissions while building strong scientific partnerships and managing program-level

Responsibilities

• Provides scientific clinical research and operational expertise for the Global Clinical Development Plan (GCDP).
• Represents Clinical Management in developing Clinical Development Plan timelines and budgets for BD opportunities.
• Ensures program standards (CRFs, outsourcing specs, slides, training) are applied across studies.
• Contributes to final analysis and development of clinical trial reports and publications.
• Develops program-level financial estimates and MLTP contributions.
• Leads program-level teams as Co-Chair or lead clinical management representative at meetings.
• Prepares and defends clinical program documents (IB/IMPD, IND/CTA reports, NDA/MA submissions).
• Leads clinical sections of regulatory submissions and inspection readiness programs.
• Develops scientific partnerships to optimize study design and publication.
• Supports HEOR strategy and endpoint development where necessary.
• Acts as Medical Affairs/PBS contact for medical information and disclosures.
• Represents programs to senior management and disseminates information.

Skills

Clinical operations

GCP knowledge

Regulatory submissions

Project leadership

Budget planning

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to lead operational strategy for global clinical programs in a remote, full-time capacity.

The role coordinates with internal departments, ESPs, and external partners to deliver trials on time and within budget. The Director will guide development plans, ensure compliance with GCP/ICH guidelines, and drive readiness for regulatory submissions while building strong scientific partnerships and managing program-level