Senior Director, Global Clinical Development — Immunology

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development with an immunology background to lead clinical strategy across programs. The role focuses on design and oversight of global trials, regulatory filings, and high standards of scientific integrity.

The position operates in a matrix, guiding multiple programs from early development through NDA/BLA filings. Travel is required, with emphasis on global regulatory interactions and vendor management.

Qualifications

• Requires clinician background (MD/DO) with immunology/rheumatology/dermatology focus and management experience.
• Extensive pharmaceutical industry and clinical research exposure expected (5+ years).
• Thorough knowledge of clinical medicine, pharmacology, biostatistics, data management, and medical writing.
• Strong understanding of global regulatory requirements and drug development.

Responsibilities

• Lead clinical development strategy and execution from proof of concept to 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 document development (INDs, IBS, CSRs, NDAs/BLAs).
• Collaborate with regulatory affairs for global health authority interactions and vendor/CRO governance.

Skills

Immunology

Leadership

Clinical development

Cross-functional leadership

Education

MD/DO

PhD/MPH/MBA a plus

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development with an immunology background to lead clinical strategy across programs. The role focuses on design and oversight of global trials, regulatory filings, and high standards of scientific integrity.

The position operates in a matrix, guiding multiple programs from early development through NDA/BLA filings. Travel is required, with emphasis on global regulatory interactions and vendor management.