Associate Director, Site and Monitoring Health
Alnylam Pharmaceuticals
August 19, 2026
On-site
United States
Clinical Research and Development
Associate Director, Site and Monitoring Health Team Lead
Responsibilities:
- Provide leadership and GCP expertise to drive the monitoring strategy for trials in assigned program(s).
- Co-direct the extended team (matrix environment) to safeguard clinical trial execution quality at investigator sites and ensure CRO monitoring effectiveness oversight.
- Line manage and matrix manage Site and Monitoring Health Regional Leads (SMH Regional Leads); direct FSP Site and Monitoring Health Leads.
- Develop, implement, and oversee Site and Monitoring Health strategy aligned with ICH GCP E6/E8; ensure monitoring plans and trial budget alignment.
- Lead/support Regional Leads in assessing CRO monitoring effectiveness across the portfolio.
- Liaise with CRO partners and internal partners (e.g., Clinical Risk & Analytics, Study Management) to align monitoring strategy and trial plans.
- Manage program-level oversight; ensure Study Specific Oversight Plans are implemented and followed.
- Drive risk-based, inspection-ready culture and maintain purposeful urgency and excellence.
- Maintain stakeholder relationships to achieve Clinical Operations goals; assist with planning and trial optimization.
- Participate in Clinical Operations workstreams/projects to improve processes; support inspection preparation.
Qualifications/Requirements:
- Bachelor’s degree required; clinical/advanced degree (RN, MPH, MS, MA, MBA, PharmD) preferred.
- Prior sponsor oversight, Site/Monitoring Health, RBQM+, and line management experience preferred.
- Experience leading teams and regional remote-based staff.
- Solid direct monitoring experience with a CRO or pharmaceutical company on multinational clinical studies; Lead CRA/CRA management preferred.
- Experience across clinical research phases (I–IV); rare medical condition experience preferred.
- Prior regulatory inspection experience preferred.
- Comprehensive, current regulatory knowledge including GCPs.
Skills:
- Strong communication for senior leaders; presentations/training experience.
- Relationship-building with investigators/sites and key stakeholders.
- Innovative, proactive problem-solving.
- Microsoft applications experience; ability to learn internal systems.
- Strong judgment/decision-making; ability to delegate and oversee delegated activities.
Travel: <25% average (occasional global travel).
U.S. Pay Range: $172,600.00 - $233,400.00. Eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
Responsibilities:
- Provide leadership and GCP expertise to drive the monitoring strategy for trials in assigned program(s).
- Co-direct the extended team (matrix environment) to safeguard clinical trial execution quality at investigator sites and ensure CRO monitoring effectiveness oversight.
- Line manage and matrix manage Site and Monitoring Health Regional Leads (SMH Regional Leads); direct FSP Site and Monitoring Health Leads.
- Develop, implement, and oversee Site and Monitoring Health strategy aligned with ICH GCP E6/E8; ensure monitoring plans and trial budget alignment.
- Lead/support Regional Leads in assessing CRO monitoring effectiveness across the portfolio.
- Liaise with CRO partners and internal partners (e.g., Clinical Risk & Analytics, Study Management) to align monitoring strategy and trial plans.
- Manage program-level oversight; ensure Study Specific Oversight Plans are implemented and followed.
- Drive risk-based, inspection-ready culture and maintain purposeful urgency and excellence.
- Maintain stakeholder relationships to achieve Clinical Operations goals; assist with planning and trial optimization.
- Participate in Clinical Operations workstreams/projects to improve processes; support inspection preparation.
Qualifications/Requirements:
- Bachelor’s degree required; clinical/advanced degree (RN, MPH, MS, MA, MBA, PharmD) preferred.
- Prior sponsor oversight, Site/Monitoring Health, RBQM+, and line management experience preferred.
- Experience leading teams and regional remote-based staff.
- Solid direct monitoring experience with a CRO or pharmaceutical company on multinational clinical studies; Lead CRA/CRA management preferred.
- Experience across clinical research phases (I–IV); rare medical condition experience preferred.
- Prior regulatory inspection experience preferred.
- Comprehensive, current regulatory knowledge including GCPs.
Skills:
- Strong communication for senior leaders; presentations/training experience.
- Relationship-building with investigators/sites and key stakeholders.
- Innovative, proactive problem-solving.
- Microsoft applications experience; ability to learn internal systems.
- Strong judgment/decision-making; ability to delegate and oversee delegated activities.
Travel: <25% average (occasional global travel).
U.S. Pay Range: $172,600.00 - $233,400.00. Eligible for annual short-term incentive and annual long-term incentive (e.g., equity).