Senior Director, Global Clinical Development – Nephrology & Immunology

Job Summary

Otsuka America Pharmaceutical Inc. is hiring a Senior Director, Global Clinical Development – Nephrology & Immunology in the Ny State Campus, Albany County, NY. This senior leadership role drives global clinical development strategy for immunology and nephrology programs with a salary of $272,267.84.

Key Responsibilities

• Define and execute global clinical development strategies across multiple nephrology and immunology programs.
• Lead cross‑functional study teams, including clinical operations, biostatistics, regulatory affairs, and medical affairs.
• Design, oversee, and monitor Phase I‑IV clinical trials ensuring scientific rigor and compliance.
• Collaborate with external investigators, key opinion leaders, and regulatory agencies to align program objectives.
• Manage budgets, timelines, and resource allocation for global clinical projects.
• Present development plans and progress to senior leadership and global steering committees.
• Mentor and develop senior clinical staff, fostering a culture of innovation and excellence.

Required Qualifications

• Advanced degree (PhD, MD, PharmD, or equivalent) in a life sciences discipline.
• 10+ years of progressive experience in global clinical development, preferably in immunology or nephrology.
• Proven track record of leading late‑stage clinical programs and successful regulatory submissions.
• Strong understanding of ICH/GCP guidelines and FDA/EMA regulatory pathways.
• Exceptional leadership, communication, and stakeholder management skills.
• Experience managing multi‑regional teams and external CRO partnerships.

Preferred Experience

• Previous senior director or equivalent role in a pharmaceutical or biotech company.
• Published research or patents in immunology or renal disease.
• Familiarity with digital clinical trial technologies and data analytics.

Frequently Asked Questions

What does the Senior Director, Global Clinical Development role entail?

The role leads global clinical strategy for nephrology and immunology programs, overseeing trial design, cross‑functional teams, budgets, and regulatory interactions.

What qualifications are required for this position?

An advanced life‑science degree, 10+ years of global clinical development experience in immunology or nephrology, and strong leadership and regulatory knowledge.

Where is the job located and what is the salary?

The position is based at Otsuka’s Ny State Campus in Albany County, NY, with a salary of $272,267.84 per year.