Remote Senior Director, Clinical Development – Nephrology

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

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Life insurance

Disability insurance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

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

You will drive trial design, regulatory filings, and cross-functional leadership in a matrix environment, ensuring scientific integrity from early development to NDA/BLA filings. The role requires deep knowledge of drug development, strong leadership, and collaboration with regulatory affairs and vendors to advance programs for

Qualifications

• Must be a clinician with immunology/rheumatology/dermatology background and management experience.
• Minimum five years of clinical research experience in pharma/academic translational work.
• Thorough knowledge of clinical medicine and pharmacology and related disciplines.
• Advanced understanding of drug development and global regulatory requirements.

Responsibilities

• Lead clinical development strategy for assigned programs from PoC to late-stage trials and regulatory submissions.
• Provide medical leadership to cross-functional study teams and ensure high-quality trial design and data interpretation.
• Lead as medical expert for assigned indications and oversee regulatory document development (INDs, IBs, CSRs, NDAs/BLAs).
• Collaborate with regulatory affairs for global health authority interactions and governance with vendors and CROs.
• Mentor junior team members and support business development via medical due diligence.

Skills

Immunology

Clinical leadership

Cross-functional collaboration

Regulatory knowledge

Medical writing

Strategic thinking

Communication skills

Data interpretation

Project management

GCP compliance

Education

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Office

Job description

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

You will drive trial design, regulatory filings, and cross-functional leadership in a matrix environment, ensuring scientific integrity from early development to NDA/BLA filings. The role requires deep knowledge of drug development, strong leadership, and collaboration with regulatory affairs and vendors to advance programs for