Associate Director, Site and Monitoring Health

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. 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. Support inspection preparation and management. Bachelor's Degree is required. 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 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; 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 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 (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff 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