Remote Director, Clinical Programs & Strategy

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

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with ESPs and internal partners, manage budgets, and ensure regulatory compliance across development plans.

Responsibilities include developing the Clinical Development Plan, coordinating timelines, and driving high-quality trial execution. Strong leadership, communication, and global regulatory knowledge are essential for success.

Qualifications

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

Responsibilities

• Provide scientific clinical research and operational expertise for Global Clinical Development Plan strategy and objectives.
• Represent Clinical Management in development of Clinical Development Plan, timelines, and budget for opportunities.
• Ensure program standards (CRFs, outsourcing specs, slides, templates) are consistent across studies.
• Contribute to final analysis and interpretation including reports, publications, and presentations.
• Develop program level financial estimates and MLTP contributions.
• Lead program teams as Co-Chair or lead clinical management rep in meetings.
• Prepare and defend clinical program documents and ongoing filings support.
• Lead development of regulatory document sections and inspection readiness programs.
• Develop partnerships with advisory experts to enhance study design and outcomes.
• Support HEOR strategy and endpoint development.
• Serve as Medical Affairs contact for information requests and publications strategies.
• Represent programs to senior management and cross-functional teams.
• Participate in ESP governance and alliance management.
• Assist with portfolio-level resource planning and staff development.
• Participate in trial data reviews for integrity and consistency.
• Ensure inspection readiness activities across programs.
• Participate in risk mitigation at program level.
• Contribute to departmental standardization and continuous improvement.

Skills

Clinical operations

GCP/ICH regulations

Vendor management

Data management

Biostatistics

Medical writing

Regulatory compliance

Leadership

Communication

Planning & budgeting

Education

Bachelor’s Degree with 14 years pharma industry experience

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with ESPs and internal partners, manage budgets, and ensure regulatory compliance across development plans.

Responsibilities include developing the Clinical Development Plan, coordinating timelines, and driving high-quality trial execution. Strong leadership, communication, and global regulatory knowledge are essential for success.