Senior Director, Global Clinical Development – Nephrology & Immunology

Otsuka America Pharmaceutical Inc. is hiring a Senior Director, Global Clinical Development – Nephrology & Immunology in Douglas, Juneau, US. This senior leadership role guides worldwide clinical development strategy, oversees multi‑program study execution, and ensures scientific excellence.

Key Responsibilities

• Define and drive global clinical development strategy for nephrology and immunology programs.
• Lead cross‑functional study teams, including clinical operations, biostatistics, regulatory, and medical affairs.
• Design, initiate, and oversee Phase I‑III clinical trials ensuring compliance with ICH/GCP standards.
• Collaborate with external partners, KOLs, and regulatory agencies to align development plans.
• Mentor and develop senior clinical staff, fostering a high‑performance culture.
• Monitor trial performance metrics, budget, timelines, and risk mitigation.
• Represent Otsuka in scientific forums, conferences, and internal executive committees.

Required Qualifications

• MD, PhD, or PharmD with 12+ years of progressive clinical development experience, preferably in immunology and nephrology.
• Proven track record of leading global Phase II/III programs to successful NDA/MAA submission.
• Strong knowledge of regulatory requirements (FDA, EMA, PMDA) and clinical trial design.
• Excellent leadership, communication, and stakeholder‑management skills.
• Experience managing multi‑million‑dollar budgets; salary range $279,189.78 annually.

Preferred Experience

• Previous senior director or VP‑level role in a pharmaceutical or biotech company.
• Published peer‑reviewed research in nephrology or immunology.
• Hands‑on experience with adaptive trial designs and biomarker strategies.

Frequently Asked Questions

What therapeutic areas does this senior director role focus on?

The position oversees global clinical development for both nephrology and immunology programs.

What level of experience is required?

At least 12 years of progressive clinical development experience, with senior leadership experience in a pharma or biotech setting.

What is the annual salary for this position?

The role offers a fixed annual salary of $279,189.78.