Associate Director, Site and Monitoring Health

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.

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.

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.

Pay

U.S. Pay Range $172,600.00 - $233,400.00. The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• Lifestyle reimbursement program.
• Flexible spending and health savings accounts.
• 401(k) with a generous company match.
• Paid time off, wellness days, holidays, and two company-wide recharge breaks.
• Generous family resources and leave.