Associate Director, Site and Monitoring Health

Alnylam Pharmaceuticals•,

1d•$172,600 - $233,400•Remote

About The Position

The Associate Director, Site and Monitoring Health Team Lead will provide strong leadership, GCP expertise and clinical operations experience to drive the monitoring strategy for trials in their assigned program(s). They are responsible for co-directing (in a matrix environment) the extended team to safeguard the quality of clinical trial execution at investigator sites and ensure Alnylam’s oversight of CRO monitoring effectiveness. The Associate Director, Site and Monitoring Health Team Lead will line manage and matrix manage Site and Monitoring Health Regional Leads (SMH Regional Leads) and direct the work of FSP Site and Monitoring Health Leads. This position reports to the Director, Clinical Operations - Site and Monitoring Health (Global).

Requirements

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; Lead CRA/CRA management experience preferred
Experience in all study phases of clinical research (Phase I-IV) and experience in rare medical conditions 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

Nice To Haves

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
Previous regulatory inspection experience preferred

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 Regional 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 Regional 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.