Global Study Start-Up Director

Alnylam Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 170,000 - 210,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to lead end-to-end SSU activities for studies, ensuring timely site activation and regulatory compliance. This role partners across Clinical Operations, Regulatory, Legal, and CROs to identify risks and drive on-time delivery.

The ideal candidate will bring 8+ years in global clinical trial operations with strong leadership, data-driven problem solving, and a deep knowledge of ICH-GCP guidelines.

Qualifications

• Bachelor’s degree in a healthcare, life sciences, or scientific discipline.
• Minimum of 8 years of experience in global clinical trial operations and/or study start-up.
• Minimum of 5 years of people leadership experience, including coaching, performance management, and development of direct reports.
• Strong understanding of global study start-up processes, regulatory pathways, and site activation models.
• Demonstrated ability to manage multiple priorities and deliver results in a matrixed environment.

Responsibilities

• Lead end-to-end study start-up activities including site feasibility, site selection, regulatory submissions, site contracting, and site activation.
• Drive early planning, risk identification, and issue management to support timelines.
• Escalation point for study-level start-up issues with cross-functional partners.
• May provide people leadership for SSU Managers or SSU Leads.
• Ensure consistent application of SSU SOPs, tools, and templates.
• Contribute to development and rollout of SSU processes, tools, and training.
• Drive standardization and best-practice adoption across studies and regions.
• Monitor study-level SSU metrics and KPIs such as activation timelines.
• Use data to identify risks and opportunities for improvement.
• Maintain country and site intelligence to support planning.
• Partner with leadership, feasibility, clinical ops, regulatory, and CROs for alignment.
• Provide oversight of CRO performance related to study start-up.
• Support inspection readiness and compliance with ICH-GCP and regulatory policies.
• Participate in continuous improvement initiatives.

Skills

Study Start-Up

Global Operations

People Leadership

ICH-GCP

Cross-functional Collaboration

Education

Bachelor’s degree in healthcare or life sciences

Job description

Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to lead end-to-end SSU activities for studies, ensuring timely site activation and regulatory compliance. This role partners across Clinical Operations, Regulatory, Legal, and CROs to identify risks and drive on-time delivery.

The ideal candidate will bring 8+ years in global clinical trial operations with strong leadership, data-driven problem solving, and a deep knowledge of ICH-GCP guidelines.