Alnylam Pharmaceuticals · 1 day ago
Associate Director Site and Monitoring Health
United States
Full-time
Remote
Lead/Staff, Director/ExecutiveAlnylam Pharmaceuticals is seeking an Associate Director, Site and Monitoring Health to provide leadership and expertise in clinical operations. This role involves driving the monitoring strategy for clinical trials, managing teams, and ensuring effective oversight of CRO monitoring effectiveness.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Hiring Manager
Adam Lentz, MBA
Responsibilities
Develop, implement, and oversee Alnylam’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8, ensuring that monitoring plans for trials assigned reflect the strategy and the trial budget is aligned
Lead, direct, and support Site and Monitoring Health Leads in assessing CRO monitoring effectiveness across the portfolio
Direct day-to-day work activities for FSP Vendor Site and Monitoring Health Leads
Liaise with CRO partners and internal partners (including Clinical Risk & Analytics and Study Management) to ensure overall understanding of monitoring strategy and alignment among trial plans
Consistently manage oversight activities at the program level as aligned and ensure Study Specific Oversight Plans are appropriately implemented and followed for all studies within scope
Drive a culture that balances purposeful urgency with passion for excellence, employ risk-based thinking to focus on what is critical to quality, and emphasize an “inspection ready at all times” mentality
Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations’ goals
Assist in planning and trial optimization to evolve the Clinical Operations organization as we scale for the future
Participate in various workstreams and projects as a leader in Clinical Operations to improve and refine processes
Ensure Site and Monitoring Health Leads complete administrative tasks on time and facilitate their continuous development
Determine resourcing needs within Site and Monitoring Health and workload allocation based on the portfolio
Support inspection preparation and management
Maintain awareness of changes in industry and regulatory standards for GCP requirements and share updates with Site and Monitoring Health Team
Travel (including occasional global travel) averages <25% but may fluctuate up or down, month over month according to business need
Qualification
Required
Bachelor's Degree is required
Proven experience in effectively leading teams and regional remote-based staff
Solid direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
Comprehensive and current regulatory knowledge, including GCPs
Ability to concisely present significant issues and criticality to senior leaders
Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
Ability to build and maintain relationships with key investigators and sites
Innovator, willing to initiate changes, introduce new ideas, and creatively problem-solve
Experience with Microsoft based applications and ability to learn internal computer systems
Effective leader and collaborator with the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment
Effectively manage and develop others to be successful at Alnylam and meet the needs of Clinical Trial Oversight and the broader organization
Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups
Demonstrate good judgment and decision-making experience
Ability to delegate tasks and oversee delegated activities
Preferred
A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred
Previous experience in Sponsor Oversight, Site and Monitoring Health, RBQM+, and Line Management preferred
Lead CRA/CRA management experience preferred
Experience in all study phases of clinical research (Phase I-IV) and experience in rare medical conditions preferred
Previous regulatory inspection experience preferred
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
Founded in 2002
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase