Associate Director, Site and Monitoring Health
Alnylam Pharmaceuticals
August 19, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Lead Site and Monitoring Health strategy for assigned programs in alignment with ICH GCP E6/E8; ensure monitoring plans and budget alignment.
- Co-direct extended teams in a matrix environment to safeguard quality of clinical trial execution at investigator sites and ensure CRO monitoring effectiveness.
- Line manage/matrix manage Site and Monitoring Health Regional Leads; direct day-to-day work of FSP Site and Monitoring Health Leads.
- Lead assessment of CRO monitoring effectiveness across the portfolio.
- Liaise with CRO 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.
- Support inspection preparation/management; maintain “inspection ready at all times” mentality using risk-based thinking.
- Determine resourcing needs and workload allocation; maintain stakeholder relationships; participate in process improvement workstreams.
Requirements (Education/Experience):
- Bachelor’s degree required; clinical/advanced degree (RN, MPH, MS, MA, MBA, PharmD) preferred.
- Experience preferred: Sponsor Oversight, Site and Monitoring Health, RBQM+, line management.
- Proven experience leading teams and remote/regional staff.
- Solid direct monitoring experience with CRO/pharma on multinational studies; CRA/CRA management preferred.
- Experience across Phase I–IV; rare disease experience preferred.
- Regulatory inspection experience preferred; comprehensive current GCP/regulatory knowledge.
Skills:
- Clear communication to senior leaders; strong interpersonal skills and presentation experience.
- Relationship building with investigators/sites and problem-solving/innovation.
- Proficient with Microsoft applications; can learn internal systems.
- Ability to manage/develop others, delegate, make sound decisions, and adjust to changing priorities.
Compensation/Benefits:
- U.S. pay range: $172,600.00–$233,400.00; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
- Benefits include medical/dental/vision, life/disability, lifestyle reimbursement, FSAs/HSAs, 401(k) match, PTO/wellness days/holidays, recharge breaks, and family resources.
Travel: <25% average (may fluctuate).
- Lead Site and Monitoring Health strategy for assigned programs in alignment with ICH GCP E6/E8; ensure monitoring plans and budget alignment.
- Co-direct extended teams in a matrix environment to safeguard quality of clinical trial execution at investigator sites and ensure CRO monitoring effectiveness.
- Line manage/matrix manage Site and Monitoring Health Regional Leads; direct day-to-day work of FSP Site and Monitoring Health Leads.
- Lead assessment of CRO monitoring effectiveness across the portfolio.
- Liaise with CRO 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.
- Support inspection preparation/management; maintain “inspection ready at all times” mentality using risk-based thinking.
- Determine resourcing needs and workload allocation; maintain stakeholder relationships; participate in process improvement workstreams.
Requirements (Education/Experience):
- Bachelor’s degree required; clinical/advanced degree (RN, MPH, MS, MA, MBA, PharmD) preferred.
- Experience preferred: Sponsor Oversight, Site and Monitoring Health, RBQM+, line management.
- Proven experience leading teams and remote/regional staff.
- Solid direct monitoring experience with CRO/pharma on multinational studies; CRA/CRA management preferred.
- Experience across Phase I–IV; rare disease experience preferred.
- Regulatory inspection experience preferred; comprehensive current GCP/regulatory knowledge.
Skills:
- Clear communication to senior leaders; strong interpersonal skills and presentation experience.
- Relationship building with investigators/sites and problem-solving/innovation.
- Proficient with Microsoft applications; can learn internal systems.
- Ability to manage/develop others, delegate, make sound decisions, and adjust to changing priorities.
Compensation/Benefits:
- U.S. pay range: $172,600.00–$233,400.00; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
- Benefits include medical/dental/vision, life/disability, lifestyle reimbursement, FSAs/HSAs, 401(k) match, PTO/wellness days/holidays, recharge breaks, and family resources.
Travel: <25% average (may fluctuate).