Global Clinical Development Leader - Immunology

Otsuka Pharmaceutical Co., Ltd; United States; On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd in the United States is seeking a Senior Director, Global Clinical Development (GCD) with deep immunology expertise to lead design, execution, and oversight of global clinical programs. This role shapes clinical strategy and drives cross-functional teams to ensure scientific integrity and successful regulatory filings.

The ideal candidate will steer late-stage trials, manage CRO/vendor relationships, and contribute to publication plans while mentoring junior staff

Qualifications

• Clinician with immunology, rheumatology or dermatology background; management exp. a plus.
• 5+ years in clinical research or pharma industry.
• Thorough knowledge of clinical medicine and clinical pharmacology.
• Understanding of global regulatory requirements and drug development lifecycles.
• Experience leading global trials and regulatory filings.

Responsibilities

• Lead clinical development strategy for assigned programs through late-stage trials and regulatory submissions.
• Provide medical leadership to cross-functional study teams and ensure high-quality trial design and data interpretation.
• Serve as medical lead for assigned indications and oversee regulatory interactions.
• Ensure trials comply with GCP, regulatory requirements, and internal processes.
• Develop clinical documents and contribute to publication plans.

Skills

Immunology

Clinical development

GCP (Good Clinical Practice)

Regulatory strategy

Biostatistics

Medical writing

Cross-functional leadership

Vendors/CRO management

Drug development

Regulatory filings

Education

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Office

Job description

Otsuka Pharmaceutical Co., Ltd in the United States is seeking a Senior Director, Global Clinical Development (GCD) with deep immunology expertise to lead design, execution, and oversight of global clinical programs. This role shapes clinical strategy and drives cross-functional teams to ensure scientific integrity and successful regulatory filings.

The ideal candidate will steer late-stage trials, manage CRO/vendor relationships, and contribute to publication plans while mentoring junior staff