Remote Director, Early-Phase Clinical Management

Otsuka America Pharmaceutical Inc.; San Juan (PR); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid holidays and leave

Tuition reimbursement

Flex time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director to lead operational strategy and management of clinical programs in collaboration with the Senior Director of Clinical Management. You will plan, execute, and complete programs per ICH/GCP guidelines and Otsuka SOPs within timelines and budget.

Responsibilities include leading cross-functional teams, developing regulatory content, contributing to HEOR strategies, and guiding ESP partnerships and risk mitigation across programs.

Qualifications

• Comprehensive knowledge of clinical operations, drug development process, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and 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.

Responsibilities

• Provide scientific clinical research and operational expertise for GCDP strategy.
• Represent Clinical Management in development of CP timelines and budgets.
• Ensure program standards (CRFs, outsourcing specs, templates) are applied across studies.
• Contribute to clinical trial reports, publications, and presentations.
• Lead program level teams and participate in governance meetings.
• Develop program-level HEOR strategy and endpoints where needed.
• Serve as Medical Affairs contact for information requests and public disclosures.
• Participate in ESP governance and alliance management activities.

Skills

Clinical operations knowledge

Regulatory compliance knowledge

Leadership & people management

Strategic thinking

Communication skills

Travel ability 25%

Education

Bachelor’s Degree with 14+ years pharma industry experience including 10 years trial management

Advanced Degree

Tools

eCRFs

IRT

CTMS

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director to lead operational strategy and management of clinical programs in collaboration with the Senior Director of Clinical Management. You will plan, execute, and complete programs per ICH/GCP guidelines and Otsuka SOPs within timelines and budget.

Responsibilities include leading cross-functional teams, developing regulatory content, contributing to HEOR strategies, and guiding ESP partnerships and risk mitigation across programs.