Global Clinical Development Lead (Immunology)

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical benefits

Dental coverage

Vision coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking an experienced Senior Director, Global Clinical Development (GCD) with an immunology background to lead the design, execution, and oversight of global clinical development programs. The role shapes clinical strategy, guides cross-functional study teams, and ensures scientific and medical integrity across early to late-stage trials.

The Senior Director, GCD drives global trials, regulatory filings, and lifecycle management, working within a matrix

Qualifications

• MD/DO or equivalent with immunology/dermatology background; advanced degrees a plus.
• 5+ years in clinical research in pharma/academia with leadership
• Deep knowledge of clinical medicine, pharmacology, biostatistics, data management, medical writing
• Understanding of global regulatory requirements and drug development lifecycle
• Experience leading global trials and regulatory filings, cross-functional collaboration

Responsibilities

• Lead clinical development strategy and execution from PoC to late-stage trials.
• 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 ensure GCP compliance.
• Oversee regulatory submissions and collaboration with regulatory affairs.
• Mentor junior team members and support external vendor relationships.
• Contribute to publication plans and scientific communications.

Skills

Immunology expertise

Leadership experience

Global clinical development

Regulatory strategy

GCP knowledge

Strong communication

Mentoring/leadership

Education

MD/DO degree

Tools

MS Office

Job description

Otsuka Pharmaceutical Co., Ltd is seeking an experienced Senior Director, Global Clinical Development (GCD) with an immunology background to lead the design, execution, and oversight of global clinical development programs. The role shapes clinical strategy, guides cross-functional study teams, and ensures scientific and medical integrity across early to late-stage trials.

The Senior Director, GCD drives global trials, regulatory filings, and lifecycle management, working within a matrix