Head of Country Operations, Clinical Development

Ipsen; Cambridge (MA); In loco; USD 177.000 - 259.000; Tempo pieno

Descrizione del lavoro

Ipsen is seeking a Country-Cluster Lead to oversee clinical operations at country level, ensuring high-quality execution, governance, and sponsor oversight across the portfolio. This role partners with FSP leadership to align local needs with global strategy and drive successful site management and monitoring.

The position requires deep experience in clinical development, RBQM, and performance management, with responsibility for country feasibility, site selection, start-up, and ongoing study

Competenze

• Requires leadership of country operations teams with site management and monitoring responsibilities.
• Experience in risk-based monitoring (RBQM) strategies and quality/regulatory compliance.
• Strong stakeholder management and collaboration with FSP partners and global functions.

Mansioni

• Lead country/cluster delivery of clinical trials on time and within budget while upholding quality standards.
• Provide end-to-end FSP governance, oversight of country feasibility, site initiation, recruitment, and study management.
• Oversee site feasibility, start-up, contracting, regulatory submissions, and inspection readiness across Ipsen studies.
• Drive Site Engagement Strategy, performance metrics, and continuous improvement in site management and monitoring.

Conoscenze

Leadership

Cross-functional leadership

Clinical trial operations

Risk-based monitoring

Stakeholder management

Data-driven decision making

Global/local balance

Formazione

Bachelor's degree in a scientific discipline or general management

Advanced degree preferred

Strumenti

eTMF

CTMS

QMS

Descrizione del lavoro

Ipsen is seeking a Country-Cluster Lead to oversee clinical operations at country level, ensuring high-quality execution, governance, and sponsor oversight across the portfolio. This role partners with FSP leadership to align local needs with global strategy and drive successful site management and monitoring.

The position requires deep experience in clinical development, RBQM, and performance management, with responsibility for country feasibility, site selection, start-up, and ongoing study