Key Responsibilities

Lead the planning, execution, and delivery of international Phase I-III clinical studies
Ensure successful study conduct through effective oversight of CROs and external vendors, with accountability for quality, timelines, budgets and study objectives
Establish and drive study governance, including risk management, issue resolution and performance oversight throughout the study lifecycle
Collaborate closely with cross-functional teams to align clinical, scientific, regulatory and operational priorities
Contribute to protocol development, study planning and operational strategies to support efficient trial execution
Ensure compliance with ICH-GCP, applicable regulations and internal standards while maintaining inspection readiness
Support interactions with health authorities and contribute to regulatory submissions, inspections and audits
Promote a culture of collaboration, accountability and continuous improvement

Your Profile

Advanced degree in Life Sciences, Pharmacy, Medicine or a related scientific field; PhD preferred
Proven track record of successfully leading international Phase I-III clinical studies
Strong expertise in CRO and vendor oversight, study governance and operational risk management
Sound understanding of clinical trial design, protocol development and study execution
In-depth knowledge of ICH-GCP and global clinical research regulations

Responsibilities

Lead the planning, execution, and delivery of international Phase I-III clinical studies
Ensure successful study conduct through effective oversight of CROs and external vendors, with accountability for quality, timelines, budgets and study objectives
Establish and drive study governance, including risk management, issue resolution and performance oversight throughout the study lifecycle
Collaborate closely with cross-functional teams to align clinical, scientific, regulatory and operational priorities
Contribute to protocol development, study planning and operational strategies to support efficient trial execution
Ensure compliance with ICH-GCP, applicable regulations and internal standards while maintaining inspection readiness
Support interactions with health authorities and contribute to regulatory submissions, inspections and audits
Promote a culture of collaboration, accountability and continuous improvement

Advanced degree in Life Sciences, Pharmacy, Medicine or a related scientific field; PhD preferred
Proven track record of successfully leading international Phase I-III clinical studies
Strong expertise in CRO and vendor oversight, study governance and operational risk management
Sound understanding of clinical trial design, protocol development and study execution
In-depth knowledge of ICH-GCP and global clinical research regulations