Remote Senior Director, Clinical Development Immunology

Otsuka America Pharmaceutical Inc.; Santa Fe (NM); Remote; USD 250,000 - 388,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development (GCD) with immunology experience to lead global clinical strategy across programs. You will shape strategy, guide cross-functional teams, and ensure high integrity in study design and data interpretation.

In this role, you will oversee regulatory submissions, collaborate with regulatory affairs, and mentor junior staff while driving optimization of late-stage trials and NDA/BLA filings in a global setting.

Qualifications

• MD or DO with immunology/rheumatology/dermatology background.
• Minimum five years in clinical research in pharma/academic translational.
• Thorough knowledge of clinical medicine and pharmacology.

Responsibilities

• Lead clinical development strategy and regulatory submissions.
• Provide medical leadership to cross-functional study teams.
• Serve as medical lead for assigned indications.
• Ensure trials comply with GCP and regulatory requirements.
• Mentor junior team members and support BD activities.

Skills

Medical leadership

Cross-functional leadership

Excellent communication

Regulatory understanding

Education

MD or DO

PhD/MPH/MBA (plus)

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development (GCD) with immunology experience to lead global clinical strategy across programs. You will shape strategy, guide cross-functional teams, and ensure high integrity in study design and data interpretation.

In this role, you will oversee regulatory submissions, collaborate with regulatory affairs, and mentor junior staff while driving optimization of late-stage trials and NDA/BLA filings in a global setting.