Strategic Study Start-Up Leader

Alnylam Pharmaceuticals; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to lead end-to-end SSU activities across assigned studies, driving site feasibility, regulatory and ethics submissions, contracting, and site activation.

You will coordinate across Clinical Operations, Regulatory, Legal, and CROs, implement SSU standards, monitor milestones, manage risks, and support inspection readiness while upholding ICH-GCP and global requirements.

Qualifications

• Bachelor’s degree in healthcare, life sciences, or a scientific discipline.
• 8+ years of global clinical trial operations and/or study start-up.
• 5+ years of people leadership experience, including coaching, performance management, and development of direct reports.
• Strong understanding of global SSU processes, regulatory pathways, and site activation models.
• Experience leading complex, multi-regional studies.
• Proven ability to partner cross-functionally and influence without authority.
• Working knowledge of ICH-GCP and the global regulatory environment.

Responsibilities

• Lead end-to-end study start-up activities for assigned studies, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation.
• Drive early planning, risk identification, and proactive issue management to support delivery of study start-up timelines.
• Serve as escalation point for study-level start-up issues, ensuring timely resolution in partnership with cross-functional stakeholders.
• May provide people leadership for Study Start-Up Managers or SSU Leads, as needed.
• Ensure consistent application of SSU SOPs, work instructions, job aids, tools, and templates across assigned studies.
• Contribute to development, refinement, and rollout of SSU processes, tools, and training materials.
• Drive standardization and best-practice adoption across studies and regions.
• Monitor and report study-level SSU metrics and KPIs (e.g., site activation timelines, readiness-to-enroll).
• Use data and insights to identify risks, trends, and opportunities for improvement, escalating as appropriate.
• Ensure accurate maintenance and use of country and site intelligence to support study planning and execution.
• Partner with Study Start-up Leadership, Feasibility, Clinical Operations, Clinical Development, Regulatory, Legal, Finance, and CROs to ensure alignment and timely execution of start-up activities.
• Provide oversight of CRO performance related to study-level start-up deliverables.
• Support inspection readiness and ensure study start-up activities comply with ICH-GCP, global regulatory requirements, and internal policies and procedures.
• Participate in continuous improvement initiatives to improve efficiency, quality, and predictability of study start-up.

Skills

People leadership

Regulatory knowledge

Analytical skills

Communication skills

Cross-functional collaboration

ICH-GCP knowledge

Education

Bachelor’s degree in healthcare, life sciences, or scientific discipline

Job description

Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to lead end-to-end SSU activities across assigned studies, driving site feasibility, regulatory and ethics submissions, contracting, and site activation.

You will coordinate across Clinical Operations, Regulatory, Legal, and CROs, implement SSU standards, monitor milestones, manage risks, and support inspection readiness while upholding ICH-GCP and global requirements.