Remote Senior Director, Clinical Development – Immunology

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

Job summary

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

You will guide cross-functional study teams, shape clinical development plans, and oversee NDA/BLA filings in a large, matrix environment. You will drive regulatory interactions, develop clinical documents, and mentor junior staff while supporting medical due diligence for business opportunities; require strong communication and

Qualifications

• A clinician (MD/DO) with immunology, rheumatology, or dermatology background and management experience.
• Experience in pharmaceutical industry and clinical research; 5+ years preferred.
• 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.
• Provide medical leadership to cross-functional teams for high-quality trial design and data interpretation.
• Serve as medical lead for assigned indications and ensure GCP compliance.
• Develop regulatory documents and collaborate with regulatory on global filings.
• Oversee vendor/CRO relationships and contribute to governance committees.
• Mentor junior team members and support business development through medical diligence.

Skills

Clinical leadership

GCP knowledge

Regulatory strategy

Cross-functional leadership

Medical writing

Immunology expertise

Strategic thinking

Communication

Education

MD or DO

PhD/MPH/MBA a plus

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

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

You will guide cross-functional study teams, shape clinical development plans, and oversee NDA/BLA filings in a large, matrix environment. You will drive regulatory interactions, develop clinical documents, and mentor junior staff while supporting medical due diligence for business opportunities; require strong communication and