Senior Global Trial Program Lead

Regulatory Jobs; Cambridge (MA); In loco; USD 150.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equity-based compensation

Medical, dental, and vision coverage

401(k) retirement plan

Life insurance

Commuter benefits

Descrizione del lavoro

Korro Bio seeks an experienced clinical operations leader to drive early-phase global trials with cross-functional teams across CROs and vendors. You will ensure trial design, regulatory alignment, data integrity, and budget adherence while coordinating study teams and site activities.

The role emphasizes leadership in rare diseases, regulatory knowledge, and strategic thinking to accelerate timelines and deliver high-quality clinical data, with some travel possible.

Competenze

• Bachelor’s Degree; Life Sciences preferred. Advanced degree desirable.
• 8+ years of relevant clinical development and operations experience in leadership roles.
• Experience in rare diseases and early phase studies is highly desirable.

Mansioni

• Plan, drive and oversee all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines in close collaborations with key stakeholders and CROs
• Drive implementation of clinical operational strategy for successful delivery of assigned clinical studies
• Use operational and therapeutic expertise to optimize trial design and execution and collaborate with the study team to accelerate timelines
• Provide oversight and management for CROs and vendors including contracting and budgets
• Coordinate and lead study team meetings and update the Program Team on timelines and milestones
• Contribute to the development of study documentation including protocol review, study plans, ICFs, and CRFs
• Contribute to CRO/vendors identification, qualification and selection processes as applicable
• Participate in study site selection; review consent forms; track patient accrual and progress; ensure eligibility and document deviations
• Oversee monitoring from site qualification to closure visits and ensure data integrity
• Oversee high quality execution and delivery of studies by CROs in alignment with budget and timeline
• Establish an open team culture with transparent communication and risk-based oversight
• Ensure compliance with policies, GCPs and regulations; ensure inspection readiness
• Oversee vendor contracts and study budgets; report progress to finance
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning and review
• Oversee TMF management and review TMF documentation
• Limited travel (<25%) to field sites to supervise and monitor studies

Conoscenze

Clinical operations

Global study leadership

Regulatory compliance

Cross-functional leadership

ICH GCP knowledge

Communication skills

Formazione

Bachelor's degree in Life Sciences

Advanced degree desirable

Descrizione del lavoro

Korro Bio seeks an experienced clinical operations leader to drive early-phase global trials with cross-functional teams across CROs and vendors. You will ensure trial design, regulatory alignment, data integrity, and budget adherence while coordinating study teams and site activities.

The role emphasizes leadership in rare diseases, regulatory knowledge, and strategic thinking to accelerate timelines and deliver high-quality clinical data, with some travel possible.