Vice President, Global Trial Optimization

Alnylam Pharmaceuticals•Cambridge, MA

About The Position

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. Also, the Vice President, Global Trial Optimization oversees patient recruitment and retention strategies and patient and site experience which maximizes acceleration and trial efficiency. As a member of the Pipeline Delivery Leadership Team, the Vice President, Global Trial Optimization is accountable for strategic feasibility and scenario planning, protocol optimization, site identification, patient recruitment and retention, patient and site experience as well as people management. Reporting to the SVP, Pipeline Delivery, the Vice President, Global Trial Optimization will lead a team of in support of all clinical trials in the Development portfolio.

Requirements

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, and urgency
Clear alignment with Alnylam Core Values
Commitment to People
Fiercely Innovative
Purposeful Sense of Urgency
Open Culture
Passion for Excellence

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

Benefits

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

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