Global Clinical Development Leader - Immunology (Remote)

Otsuka America Pharmaceutical Inc.; Honolulu (HI); On-site; USD 250,000 - 388,000; Full time

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global strategy and execution for multiple programs.

You will guide cross‑functional teams, ensure GCP adherence, and provide medical leadership across clinical trials and regulatory filings. The role involves strategic oversight from early development to NDA/BLAs, vendor governance, and collaboration with regulatory authorities in a global setting.

Qualifications

• Clinician with medical degree and leadership experience in pharma or biotech.
• Experience in immunology or related fields preferred.
• Extensive knowledge of clinical medicine, pharmacology and regulations.

Responsibilities

• Define global clinical development strategy across programs.
• Lead cross-functional study teams and ensure trial quality.
• Serve as medical lead for assigned indications and regulatory interactions.
• Oversee clinical study designs, SDs and regulatory documents.
• Mentor junior team members and support business development due diligence.

Skills

Leadership

Cross-functional

Clinical development

GCP/regulatory

Medical leadership

Vendor management

Mentorship

Communication

MS Office

Education

MD or DO

Supplementary degrees (PhD, MPH, MBA)

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical, Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global strategy and execution for multiple programs.

You will guide cross‑functional teams, ensure GCP adherence, and provide medical leadership across clinical trials and regulatory filings. The role involves strategic oversight from early development to NDA/BLAs, vendor governance, and collaboration with regulatory authorities in a global setting.