Global Clinical Development Leader, Immunology & Nephrology

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking an experienced Senior Director, Global Clinical Development, with immunology expertise to lead global clinical development strategy across multiple programs.

The role drives scientific integrity, leads cross-functional study teams, and oversees clinical research programs for OPDC products under GCP. The incumbent will contribute to NDA/BLA filings, engage with global health authorities, and mentor junior staff within a multi-disciplinary matrix

Qualifications

• MD or DO with immunology/rheumatology/dermatology background; management experience preferred.
• Minimum five years of clinical research experience in pharma/academic translational clinical research.
• Thorough knowledge of clinical medicine, pharmacology and related disciplines.
• Advanced understanding of drug development and global regulatory requirements.

Responsibilities

• Lead clinical development strategy and execution from proof of concept to late-stage trials and 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.
• Partner with regulatory affairs and ensure trials meet GCP and regulatory requirements.
• Develop clinical sections of regulatory documents (INDs, IBs, clinical study reports, NDAs/BLAs).
• Mentor junior team members and support business development via medical due diligence.

Skills

Clinical leadership

Strategic thinking

Cross-functional collaboration

Mentoring team

Regulatory understanding

Communication skills

Project management

Education

MD or DO (immunology/dermatology/rheumatology)

Supplementary degrees (e.g., PhD, MBA)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Regulatory writing tools

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking an experienced Senior Director, Global Clinical Development, with immunology expertise to lead global clinical development strategy across multiple programs.

The role drives scientific integrity, leads cross-functional study teams, and oversees clinical research programs for OPDC products under GCP. The incumbent will contribute to NDA/BLA filings, engage with global health authorities, and mentor junior staff within a multi-disciplinary matrix