VP, Global Trial Optimization

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, and urgency

Clear alignment with Alnylam Core Values

Commitment to People

Fiercely Innovative

Purposeful Sense of Urgency

Open Culture

Passion for Excellence

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.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below 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

U.S. Pay Range $301,800 — $408,200 USD