Remote Senior Director, Clinical Development – Immunology

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

Benefits offered by this job

Great Place to Work certification

Comprehensive benefits package

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to shape clinical strategy across programs. You will lead cross-functional teams, guide trial design, and oversee regulatory submissions from IND through NDA/BLAs, in a global setting.

The role requires deep clinical development knowledge and strong leadership in a matrix environment. The position emphasizes collaboration with regulatory affairs, vendors, and KOLs, and involves

Qualifications

• Clinician with MD/DO, with immunology/rheumatology/dermatology background and leadership experience.

Responsibilities

• Lead clinical development strategy and execution from proof of concept 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 regulatory alignment.
• Collaborate with regulatory affairs for global health authority interactions.
• Oversee clinical sections of regulatory documents (INDs, IBs, CSRs, NDAs/BLAs).
• Mentor junior team members and support business development through medical due diligence.

Skills

Clinical leadership

Immunology knowledge

Regulatory understanding

Cross-functional collaboration

Medical writing/comms

Data interpretation

Microsoft Office

Education

MD/DO (Immunology/Rheumatology/Dermatology)

PhD/MPH/MBA (plus)

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to shape clinical strategy across programs. You will lead cross-functional teams, guide trial design, and oversee regulatory submissions from IND through NDA/BLAs, in a global setting.

The role requires deep clinical development knowledge and strong leadership in a matrix environment. The position emphasizes collaboration with regulatory affairs, vendors, and KOLs, and involves