Remote Senior Director, Clinical Development – Immunology

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

Benefits offered by this job

Comprehensive benefits

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global clinical strategy across programs, overseeing trial design, execution, and interpretation under GCP, and guiding NDA/BLA submissions.

The role requires strong cross-functional leadership and mentorship in a matrix environment. The incumbent will drive strategic development across therapeutic areas, manage regulatory interactions, and collaborate with KOLs and external

Qualifications

• MD/DO required with immunology, rheumatology, or dermatology background
• Minimum of five years' clinical research experience in pharma/academia
• Thorough knowledge of clinical medicine and related disciplines
• Experience leading regulatory interactions and submissions preferred

Responsibilities

• Lead clinical development strategy and execution for assigned programs from proof of concept 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 and mentor junior team members and manage vendor/CRO relationships.
• Collaborate with regulatory affairs for interactions with global health authorities and for regulatory filings.
• Support business development through medical due diligence and external opportunity evaluation.

Skills

MD/DO background

Immunology

Clinical development leadership

GCP knowledge

Regulatory affairs knowledge

Cross-functional leadership

Medical writing

Education

MD/DO degree

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global clinical strategy across programs, overseeing trial design, execution, and interpretation under GCP, and guiding NDA/BLA submissions.

The role requires strong cross-functional leadership and mentorship in a matrix environment. The incumbent will drive strategic development across therapeutic areas, manage regulatory interactions, and collaborate with KOLs and external