VP, Global Trial Optimization

Job description

Overview Alnylam is seeking an experienced leader to drive the strategy and execution of clinical trial optimization across our development portfolio. As Vice President, Global Trial Optimization, you will lead strategic feasibility, protocol optimization, scenario planning, and patient recruitment, retention, and experience initiatives to help accelerate clinical development and improve trial performance. As a member of the Pipeline Delivery Leadership Team and reporting to the SVP, Pipeline Delivery, you will lead a team that supports all clinical trials across the portfolio. In this role, you will partner across functions to ensure studies are designed and delivered efficiently, using data-driven insights and patient-centered approaches to accelerate the delivery of therapies to patients worldwide. Key Responsibilities Drives a Feasibility Center of Excellence and partners with our 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 the 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, milestone, and enrollment assumptions; leads clinical operations lock (CLOCK) reviews and partners with study team to communicate CLOCK milestones at governance forums Facilitates site identification and outlines best fit site archetype Accountable for predictable and consistent delivery of patient recruitment & 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 relevant discipline strongly preferred 20+ years industry experience focused on Clinical Operations, including global clinical trial conduct, feasibility, protocol optimization, patient recruitment and retention, and working with global CROs 10+ year 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, Monte Carlo simulations etc. Proven experience in data analysis, data interpretation to drive informed decision making A 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 CRF 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 leader. Able to hold teams accountable to deliverables Ability to travel up to 30% Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion, a