Remote Senior Director, Immunology & Nephrology Development

Otsuka America Pharmaceutical Inc.; Phoenix (AZ); Remote; USD 250,000 - 388,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with a strong immunology background to lead global clinical development Strategy.

The role drives cross-functional trial design, execution, and data interpretation across programs and supports NDA/BLAs. The position requires deep understanding of drug development from early phases to post-commercialization, and involves management of global trials, regulatory interactions, and vendor oversight in a

Qualifications

• MD/DO with immunology background; PhD/MPH/MBA a plus.
• 5+ years of clinical research or pharmaceutical industry experience.
• Thorough knowledge of clinical medicine and regulatory requirements.
• Advanced understanding of drug development and global trials.
• Proven ability to lead cross-functional teams and communicate clearly.

Responsibilities

• Lead global clinical development strategy for assigned programs.
• Provide medical leadership to cross-functional study teams.
• Serve as medical lead for indications and trials.
• Ensure trials comply with GCP and regulatory requirements.
• Contribute to regulatory documents and NDA/BLAs.
• Oversee vendor and CRO relationships and governance.
• Lead discussions with KOLs and advisory boards.
• Mentor junior team members and support BD due diligence.

Skills

Strategic leadership

Clinical trial design

Regulatory filing experience

Immunology expertise

Team leadership

GCP knowledge

Education

MD/DO

Advanced degree a plus

Tools

Microsoft Office Suite

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with a strong immunology background to lead global clinical development Strategy.

The role drives cross-functional trial design, execution, and data interpretation across programs and supports NDA/BLAs. The position requires deep understanding of drug development from early phases to post-commercialization, and involves management of global trials, regulatory interactions, and vendor oversight in a