Global GCD Director, Immunology & Nephrology (Remote)

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

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision coverage

Prescription drug coverage

401(k) match

Flexible time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development with expertise in immunology to lead global clinical development strategies across multiple programs.

The role involves shaping clinical strategy, leading cross-functional teams, and ensuring high standards of scientific integrity from early development to NDA/BLA filings. The position requires deep knowledge of drug development processes, regulatory interactions, and vendor/CRO governance, with travel

Qualifications

• Requires clinician with immunology/rheumatology/dermatology background and management experience.
• Minimum five years of clinical research experience in pharma/academic translational settings.
• Thorough knowledge of clinical medicine, pharmacology and related disciplines.
• Advanced understanding of drug development, regulatory requirements and global filings.
• Experience leading regulatory interactions and submissions is a plus.

Responsibilities

• Lead clinical development strategy and execution from proof of concept through late-stage trials and regulatory submissions.
• Provide medical leadership to cross-functional study teams ensuring high-quality trial design, conduct and data interpretation.
• Serve as medical lead for assigned indications and ensure trials comply with GCP and regulatory requirements.
• Develop regulatory documents including INDs, IBs, clinical study reports, and NDAs/BLAs; collaborate with regulatory affairs.

Skills

Immunology

Clinical leadership

GCP knowledge

Regulatory strategy

Cross-functional leadership

Education

MD/DO

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development with expertise in immunology to lead global clinical development strategies across multiple programs.

The role involves shaping clinical strategy, leading cross-functional teams, and ensuring high standards of scientific integrity from early development to NDA/BLA filings. The position requires deep knowledge of drug development processes, regulatory interactions, and vendor/CRO governance, with travel