Strategic Study Start-Up Lead

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA, seeks an Associate Director, Study Start-Up to lead end-to-end SSU activities and deliver site activation on a predictable timeline. You will drive planning, regulatory submissions, site contracts, and activation, ensuring standard SSU processes are followed.

In this role you will partner with Clinical Operations, Regulatory, Legal and CROs, provide people leadership when needed, monitor SSU metrics, and push continuous improvement to increase

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 and developing direct reports.
• Strong understanding of global study start-up processes, regulatory pathways, and site activation models.
• Proven ability to manage multiple priorities in a matrixed environment.
• Excellent analytical, problem-solving, and communication skills.
• Experience leading multi-regional studies and process improvement initiatives.

Responsibilities

• Lead end-to-end SSU activities for assigned studies, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and activation.
• Drive early planning, risk identification, and proactive issue management to support timely start-up timelines.
• Serve as escalation point for study-level start-up issues with cross-functional stakeholders.
• May provide people leadership for SSU Managers or SSU Leads as needed.
• Ensure consistent application of SSU SOPs, work instructions, tools, and templates across studies.
• Contribute to development 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., activation timelines, readiness-to-enroll).
• Use data to identify risks and opportunities for improvement and escalate appropriately.
• Maintain accurate country and site intelligence to support planning and execution.
• Partner with SSU Leadership, Feasibility, Clinical Operations, Regulatory, Legal, Finance, and CROs for timely execution.
• Provide oversight of CRO performance related to start-up deliverables.
• Support inspection readiness and ensure SSU activities comply with ICH-GCP and regulatory requirements.
• Participate in continuous improvement initiatives to enhance efficiency and quality.

Skills

Cross-functional leadership

Regulatory knowledge

ICH-GCP familiarity

Analytical skills

Communication

Education

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

Job description

Alnylam Pharmaceuticals in Cambridge, MA, seeks an Associate Director, Study Start-Up to lead end-to-end SSU activities and deliver site activation on a predictable timeline. You will drive planning, regulatory submissions, site contracts, and activation, ensuring standard SSU processes are followed.

In this role you will partner with Clinical Operations, Regulatory, Legal and CROs, provide people leadership when needed, monitor SSU metrics, and push continuous improvement to increase