Global Clinical Development Director

Otsuka America Pharmaceutical Inc.; Dover (DE); On-site; USD 210,000 - 313,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC products, focusing on CNS and digital medicine for a global market. The role requires strategic clinical leadership and regulatory acumen.

You will drive program strategies, oversee trials, and collaborate with regulatory agencies, medical affairs, and external partners to optimize trials and ensure timely development and approval.

Qualifications

• Clinician with MD/DO; nephrologist or immunologist preferred; additional degrees a plus.
• Industry or translational clinical research experience (1–9 years depending on level).
• Strong knowledge of clinical medicine and science management to meet business outcomes.

Responsibilities

• Designs and oversees clinical research programs and protocols under GCP.
• Serves as internal medical/scientific consultant to multiple teams and external regulators.
• Authors program strategies and oversees essential trials for safety, efficacy, and value.
• Interprets Phase I–IV data for NDA submissions and regulatory communications.
• Leads vendor/CRO oversight and contributes to governance.
• Supports regulatory filings and prepares written/verbal communications.

Skills

Clinical development

GCP expertise

Regulatory filings

Team leadership

Biostatistics

Medical writing

Budget planning

Global clinical strategy

Travel management

Education

MD/DO (clinician)

PhD/MPH/MBA (plus)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical, Inc. seeks a Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC products, focusing on CNS and digital medicine for a global market. The role requires strategic clinical leadership and regulatory acumen.

You will drive program strategies, oversee trials, and collaborate with regulatory agencies, medical affairs, and external partners to optimize trials and ensure timely development and approval.