Remote Global Clinical Development Director

Otsuka America Pharmaceutical Inc.; Augusta (ME); A distancia; USD 210.000 - 313.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

401(k) match

Paid time off

Paid holidays

Descripción de la vacante

Otsuka America Pharmaceutical Inc. seeks a Director, Global Clinical Development to design and oversee clinical programs for OPDC products in a global market.

You will advise on trial design, work with health authorities, and drive strategies for successful regulatory submissions. You will lead a diverse team across nephrology, immunology and dermatology indications, collaborating with medical affairs, regulatory, statistics and data management to deliver high-impact programs while aligning with

Formación

• Clinician with M.D. or D.O., specialty in nephrology, immunology or dermatology.
• Experience in pharma or translational clinical research (1–9 years depending on level).
• Strong knowledge of clinical medicine and science management.
• Excellent written and oral communication; proficient Microsoft Office.
• Willingness to travel up to 30% and travel internationally.

Responsabilidades

• Design and oversight of clinical research programs and protocols.
• Serve as internal medical/scientific consultant to cross-functional teams and regulators.
• Authors program strategies and oversees trials for safety and efficacy.
• Interpret Phase I–IV results for NDA submissions and regulatory filings.
• Lead vendor/CRO relationships and support regulatory filings.

Conocimientos

Clinical development

Regulatory filings

Cross-functional leadership

Strategic thinking

Written and verbal communication

Educación

M.D./D.O. degree

Ph.D., M.P.H., MBA (plus)

Herramientas

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descripción del empleo

Otsuka America Pharmaceutical Inc. seeks a Director, Global Clinical Development to design and oversee clinical programs for OPDC products in a global market.

You will advise on trial design, work with health authorities, and drive strategies for successful regulatory submissions. You will lead a diverse team across nephrology, immunology and dermatology indications, collaborating with medical affairs, regulatory, statistics and data management to deliver high-impact programs while aligning with