Vice President, Global Trial Optimization

About the role

The Vice President, Global Trial Optimization leads strategic feasibility, protocol optimization, and scenario planning to inform clinical trial design that aligns the science with data-driven, efficient delivery plans. This role oversees patient recruitment and retention strategies and patient and site experience to maximize acceleration and trial efficiency. As a member of the Pipeline Delivery Leadership Team, the Vice President is accountable for strategic feasibility, scenario planning, protocol optimization, site identification, patient recruitment and retention, patient and site experience, and people management.

Reporting to the SVP, Pipeline Delivery, this role leads a team supporting all clinical trials in the Development portfolio.

Responsibilities

• Drives a Feasibility Center of Excellence and partners with preferred CROs to deliver data-driven, accurate, and optimal clinical trial scenario plans for country placement, enrollment rates, and study timelines; designs and develops feasibility tools and processes.
• Leads country placement discussions at Program Leadership Team and outlines country placement recommendations for clinical trials in support of business and trial needs; represents Clinical Operations at governance forums (e.g., DevBoard, DOC, PLT) as appropriate.
• Leads protocol feasibility and scenario modeling and recommends optimized trial delivery strategies for country and site placement, enrollment rates, site identification, and trial milestones that inform decision-making at governance forums.
• Oversees clinical trial enrollment modeling and identifies the best path to clinical trial patients; models the impact of inclusion/exclusion criteria on enrollment potential and trial timelines.
• Partners with study teams and CROs to provide data-driven, accurate study timelines, milestones, and enrollment assumptions; leads clinical operations lock (CLOCK) reviews and partners with the study team to communicate CLOCK milestones at governance forums.
• Facilitates site identification and outlines the best-fit site archetype.
• Accountable for predictable and consistent delivery of patient recruitment and retention strategies. Leads identification and selection of portfolio-level recruitment strategies and sourcing, with a focus on reduced patient burden and diversity where appropriate.
• Provides robust estimates for the impact of patient recruitment programs on trial enrollment and cost.
• Identifies and analyzes important connections within and across therapeutic areas to optimize study planning and performance at the portfolio level.

Qualifications

• MSc, MBA, PhD, or equivalent in a relevant discipline strongly preferred.
• 20+ years of industry experience focused on Clinical Operations, including global clinical trial conduct, feasibility, protocol optimization, patient recruitment and retention, and working with global CROs.
• 10+ years of team leadership, building strong feasibility and patient recruitment teams.
• Thorough understanding of clinical trial feasibility and scenario planning, including demonstrated experience with supportive tools, technologies, and Monte Carlo simulations.
• Proven experience in data analysis and data interpretation to drive informed decision-making.
• Thorough understanding of the processes associated with feasibility, protocol optimization, site identification, patient recruitment, and retention.
• Extensive experience in patient recruitment campaigns.
• Demonstrated ability to deliver results and achieve objectives within budget and timeline constraints; proven experience in cost optimization and reduction.
• Extensive experience in pharmaceutical/biotechnology and extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical trials.
• Comfortable working with Senior Executive Teams.
• Well-networked with industry peers.
• Strong project management skills and effective matrix leadership; able to hold teams accountable to deliverables.
• Ability to travel up to 30%.
• Thrives in a highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion, and urgency.
• Clear alignment with Alnylam Core Values: Commitment to People, Fiercely Innovative, Purposeful Sense of Urgency, Open Culture, Passion for Excellence.

Pay

U.S. Pay Range: $301,800.00 - $408,200.00. The pay range reflects the full-time base salary range expected for this role at the time of posting. Base pay will be determined based on 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.

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 breakthroughs that made RNAi therapeutics possible and is 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.