Associate Director, Clinical Operations

Responsibilities:

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).

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 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

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).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

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. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.