Global Clinical Development Director - Remote

Otsuka America Pharmaceutical Inc.; Boise (ID); Remoto; USD 210.000 - 313.000; Tempo pieno

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC-GCD. This role advances rheumatology, immunology and specialty medicine programs for global markets under GCP.

You will collaborate with medical affairs, regulatory and CROs, lead trial strategies, and drive regulatory submissions while ensuring high-quality, timely delivery and value creation.

Competenze

• Clinician with advanced medical degree and leadership experience in pharmaceutical research.
• Experience in clinical development and medical strategy within pharma/academia.
• Strong communication and cross-functional collaboration skills.
• Familiarity with regulatory filings and healthcare regulations.
• Experience managing teams and external investigators or CROs.

Mansioni

• Designs and oversees clinical research programs and protocols under GCP.
• Leads evaluation and development of Rheumatology, Immunology and Specialty Medicine products.
• Advises internal teams and external regulators on trial objectives and designs.
• Authors program strategies and oversees trials for safety, efficacy and value.
• Interprets Phase I–IV results for regulatory submissions and communications.
• Provides strategic direction in regulatory filings and clinical documentation.

Conoscenze

Clinical research leadership

GCP knowledge

Regulatory filings

Team management

Effective communication

Formazione

MD or DO (nephrology/immunology/dermatology)

Strumenti

Microsoft Word

Excel

PowerPoint

Outlook

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC-GCD. This role advances rheumatology, immunology and specialty medicine programs for global markets under GCP.

You will collaborate with medical affairs, regulatory and CROs, lead trial strategies, and drive regulatory submissions while ensuring high-quality, timely delivery and value creation.