Senior Director, Global Clinical Development – Immunology

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Senior Director, Global Clinical Development (GCD) with immunology expertise to lead global strategy and execution across programs.

The role requires leadership across cross‑functional teams, oversight of trial design, and regulatory engagement to support NDA/BLA filings. The position emphasizes strategic development, medical governance, and mentorship within a remote, full‑time environment with occasional international and domestic

Qualifications

• MD/DO with immunology/rheumatology/dermatology background; management experience considered.
• 5+ years in clinical research in pharma/academia.
• Thorough knowledge of clinical medicine, pharmacology, biostatistics, data management, medical writing.
• Advanced understanding of drug development and global regulatory requirements.

Responsibilities

• Lead clinical development strategy and execution from proof of concept to late-stage trials.
• 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 submissions (INDs, IBs, CSRs, NDAs/BLAs).
• Collaborate with regulatory affairs on global health authority interactions.
• Oversee vendor/CRO relationships and governance; guide publication plans and manuscripts.

Skills

Clinical leadership

Global clinical development

Regulatory knowledge

GCP knowledge

Cross-functional collaboration

Strategic thinking

Communication skills

Mentoring

Immunology expertise

Education

MD/DO

PhD/MPH/MBA

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Senior Director, Global Clinical Development (GCD) with immunology expertise to lead global strategy and execution across programs.

The role requires leadership across cross‑functional teams, oversight of trial design, and regulatory engagement to support NDA/BLA filings. The position emphasizes strategic development, medical governance, and mentorship within a remote, full‑time environment with occasional international and domestic