VP, Global Trial Optimization

Overview

The Vice President, Global Trial Optimization leads strategic feasibility 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 site identification and activation, in addition to recruitment and retention strategies, which maximize acceleration and trial efficiency. As a member of the Clinical Operations Leadership Team, the Vice President, Global Trial Optimization is accountable for strategic feasibility and scenario planning, site identification, study start-up, patient recruitment and retention, as well as people management.

Reporting to the SVP, Clinical Operations, the Vice President, Global Trial Optimization will lead a team of <10 individuals in support of all clinical trials in the Development portfolio.

Key Responsibilities

• Builds 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 delivery of predictable and consistent study start-up activities in partnership with CRO and study teams; leads targeted study start-up activities, including protocol simulations and walkthroughs; implements appropriate processes, tools and technologies that support efficient and predictable execution of start-up
• Oversees provisioning of start-up data to enable timely visibility of progress and on-time performance
• 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, study start-up, patient recruitment and retention, and working with global CROs
• 10+ year team leadership, building strong feasiblity, study start-up 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 feasiblity, site identification, trial study start-up, 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: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.