Responsibilities:

The Associate Director, Site and Monitoring Health 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 will line manage and matrix manage Site and Monitoring Health staff and direct the work of FSP Site and Monitoring Health Leads. This position reports to the Director, Site and Monitoring Health or above.

Summary of Key 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.

Requirements

• 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

Skills

• 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

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.