Director, Global Clinical Programs & Strategy

BioSpace; États-Unis; Sur place; USD 186 000 - 279 000; Plein temps

Résumé du poste

Otsuka is seeking a Director to oversee the operational strategy and management of clinical programs, coordinating with internal teams and external service providers to ensure trials are delivered on time and within budget.

The role requires extensive leadership in clinical development, regulatory readiness, and collaboration with therapeutic area experts to optimize trial design and reporting. A robust understanding of GCP/ICH, SOPs, and CRO management is essential.

Qualifications

• Comprehensive knowledge of clinical operations, drug development processes, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of SOWs.
• Advanced understanding of drug development principles and trial management.
• Strong regulatory, biostatistics, data management, and medical writing knowledge.
• Excellent communication, planning, and people management skills.

Responsabilités

• Provides scientific clinical research and operational expertise for Global Clinical Development Plan strategy.
• May represent Clinical Management in plans, timelines, and budget for opportunities.
• Ensures program standards (CRFs, outsourcing specs, templates) are applied consistently.
• Contributes to final analysis, trial reports, publications, and presentations.
• Leads program-level teams as Co-Chair and/or lead clinical management rep for meetings.
• Develops HEOR strategy input and supports regulatory submissions and public disclosures.

Connaissances

Clinical operations

GCP/ICH knowledge

Regulatory compliance

Biostatistics

Data management

Medical writing

Travel readiness (25%)

Formation

Bachelor’s Degree with 14+ years pharma industry experience including 10 years clinical trial management

Outils

eCRFs

IRT

CTMS

Description du poste

Otsuka is seeking a Director to oversee the operational strategy and management of clinical programs, coordinating with internal teams and external service providers to ensure trials are delivered on time and within budget.

The role requires extensive leadership in clinical development, regulatory readiness, and collaboration with therapeutic area experts to optimize trial design and reporting. A robust understanding of GCP/ICH, SOPs, and CRO management is essential.