Remote Global Clinical Development Director

Otsuka America Pharmaceutical Inc.; Austin (TX); Remote; USD 210,000 - 313,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid holidays and paid leave

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Director, Global Clinical Development to design and oversee clinical programs for OPDC products under GCP. The role focuses on CNS and digital medicine with global development and regulatory activities.

The position requires an MD/DO, strong leadership, and regulatory expertise, with 30% travel and collaboration across medical, regulatory and commercial teams to advance trial programs and submissions.

Qualifications

• Physician (MD/DO) with nephrology, immunology or dermatology focus preferred
• Experience in pharma industry or translational clinical research (1–3 yrs for Associate Director; 3–6 for Director; 6–9 for Senior Director)
• Strong knowledge of clinical medicine and science management
• Excellent written and verbal communication skills; proficient with MS Office

Responsibilities

• Designs and oversees clinical research programs and protocols under GCP
• Provides internal medical/scientific consultation to cross-functional teams and regulators
• Authors program strategies and oversees trials to determine safety, efficacy and value
• Interprets Phase I–IV data for NDA submissions
• Leads and mentors team members and external investigators
• Supports regulatory filings and provides strategic direction for communications

Skills

Clinical leadership

Regulatory filings

NDA submissions

GCP compliance

Vendor management

Global regulatory

Effective communication

Team leadership

Education

MD/DO

PhD MBA a plus

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical, Inc. seeks a Director, Global Clinical Development to design and oversee clinical programs for OPDC products under GCP. The role focuses on CNS and digital medicine with global development and regulatory activities.

The position requires an MD/DO, strong leadership, and regulatory expertise, with 30% travel and collaboration across medical, regulatory and commercial teams to advance trial programs and submissions.