Global Cell Therapy Clinical Operations Lead

Aspect Biosystems Ltd.; Fremont (CA); Presencial; USD 185.000 - 270.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity

Comprehensive benefits package

Career development support

Descripción de la vacante

Aspect Biosystems Ltd. seeks a Director of Clinical Operations to lead global Phase I-III cell therapy trials. You will drive operational strategy, manage cross-functional teams, and partner with vendors to ensure quality and on-time delivery.

You will oversee study budgets, site activation, recruitment strategies, and regulatory submissions while maintaining ICH-GCP compliance in a fast-paced biotech setting.

Formación

• Bachelor's degree in Life Sciences or related field is required.
• 8 years of clinical trial experience with 4 years in leadership.
• Experience in cell/gene therapy products and early development.
• Strong knowledge of ICH-GCP and global regulatory frameworks.

Responsabilidades

• Lead end-to-end operational strategy and execution of multicenter trials.
• Direct cross-functional study teams and manage budgets and timelines.
• Oversee vendor selection, negotiations, and performance governance.
• Develop site activation plans and recruitment strategies for trials.
• Ensure regulatory submissions and ethics approvals across regions.

Conocimientos

Leadership

Clinical operations

Program management

Vendor management

Budgeting

Regulatory affairs

Educación

Bachelor's degree in Life Sciences

Master's degree beneficial

Herramientas

eTMF systems

Descripción del empleo

Aspect Biosystems Ltd. seeks a Director of Clinical Operations to lead global Phase I-III cell therapy trials. You will drive operational strategy, manage cross-functional teams, and partner with vendors to ensure quality and on-time delivery.

You will oversee study budgets, site activation, recruitment strategies, and regulatory submissions while maintaining ICH-GCP compliance in a fast-paced biotech setting.