Remote Senior Director, Global Clinical Development

Otsuka America Pharmaceutical Inc.; Olympia (WA); 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

Tuition reimbursement

Student loan assistance

Paid time off / holidays

Disability insurance

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global clinical development strategy across programs.

This role shapes clinical strategy, directs cross-functional study teams, and ensures rigorous GCP-compliant research and NDA/BLAs filings. The successful candidate will drive medical strategy, collaborate with regulatory affairs, and mentor junior teammates in a matrix environment while supporting business development

Qualifications

• Clinician with immunology, rheumatology, or dermatology background and management experience.
• Experience in the pharmaceutical industry and clinical research, five+ years preferred.
• Thorough knowledge of clinical medicine, pharmacology, biostatistics, data management, and medical writing.

Responsibilities

• Lead clinical development strategy and execution from proof of concept to regulatory submissions.
• Provide medical leadership to cross-functional study teams and ensure high-quality trial design.
• Serve as medical lead for assigned indications and oversee regulatory documents.
• Collaborate with regulatory affairs on interactions with global health authorities.
• Manage vendor/CRO relationships and provide clinical input to governance committees.
• Lead discussions with KOLs and advisory boards; develop clinical documents and publications.

Skills

Immunology

Clinical development leadership

Regulatory strategy

Education

MD/DO required

PhD/MPH/MBA a plus

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global clinical development strategy across programs.

This role shapes clinical strategy, directs cross-functional study teams, and ensures rigorous GCP-compliant research and NDA/BLAs filings. The successful candidate will drive medical strategy, collaborate with regulatory affairs, and mentor junior teammates in a matrix environment while supporting business development