Global Clinical Development Director — Immunology

Otsuka Pharmaceutical Companies (U.S.); United States; Vor Ort; USD 231.000 - 345.000; Vollzeit

Benefits dieser Stelle

Comprehensive medical, dental, vision

401(k) with match

Paid holidays and leave programs

Zusammenfassung

Otsuka is seeking a Senior Director, Global Clinical Development with an immunology background to lead design, execution and oversight of global clinical development programs. This role will shape clinical strategy, guide cross-functional study teams, and ensure scientific and medical integrity throughout the development lifecycle.

The successful candidate will oversee trials from early clinical stages to post-approval, leading regulatory submissions and collaborations with global health

Qualifikationen

• Clinical research experience in pharma with at least five years.
• Thorough knowledge of clinical medicine and drug development.
• Leadership of cross-functional teams in global trials.

Aufgaben

• Lead global clinical development strategy and execution for programs.
• Provide medical leadership to study teams and ensure high-quality trial design and data interpretation.
• Serve as medical lead for assigned indications and regulatory interactions.
• Collaborate with regulatory affairs on global authorities interactions.
• Develop clinical documents including monitoring plans and asset development plans.

Kenntnisse

Strategic leadership

Cross-functional collaboration

Regulatory affairs knowledge

Medical/clinical leadership

Communication skills

Project management

Ausbildung

MD/DO degree

PhD/MPH/MBA (plus)

Tools

MS Word

Excel

PowerPoint

Outlook

Jobbeschreibung

Otsuka is seeking a Senior Director, Global Clinical Development with an immunology background to lead design, execution and oversight of global clinical development programs. This role will shape clinical strategy, guide cross-functional study teams, and ensure scientific and medical integrity throughout the development lifecycle.

The successful candidate will oversee trials from early clinical stages to post-approval, leading regulatory submissions and collaborations with global health