Head of Global Trial Optimization & Feasibility

Alnylam Pharmaceuticals; Cambridge (MA); Sur place; USD 302 000 - 408 000; Plein temps

Résumé du poste

Alnylam Pharmaceuticals seeks an experienced Vice President, Global Trial Optimization, to lead feasibility, protocol optimization, and patient recruitment across the development portfolio. You will drive scenario planning, enrollment modeling, and governance engagement to accelerate clinical development and improve trial performance.

You will lead a team supporting all trials, partnering across functions to design efficient studies using data-driven insights and patient-centered approaches

Qualifications

• MSc, MBA, PhD or equivalent in a relevant discipline strongly preferred.
• 20+ years of experience in Clinical Operations including global 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.
• 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

Responsabilités

• Leads feasibility Center of Excellence and partners with CROs to deliver data-driven trial scenario plans for country placement, enrollment rates and study timelines
• Leads country placement discussions for trials and represents Clinical Operations at governance forums
• Leads protocol feasibility and scenario modeling and recommends optimized trial delivery strategies for country and site placement
• Oversees clinical trial enrollment modeling and analyzes impact of inclusion/exclusion criteria on enrollment and timelines
• Partners with study teams and CROs to provide data-driven study timelines, milestones, and enrollment assumptions; leads CLOCK reviews
• Facilitates site identification and outlines best-fit site archetype
• Accountable for recruitment and retention strategies with diversity focus
• Provides robust estimates for impact of recruitment programs on enrollment and cost
• Identifies connections across therapeutic areas to optimize study planning at portfolio level

Connaissances

Clinical Operations leadership

Global CRO collaboration

Feasibility and protocol optimization

Patient recruitment and retention

Data-driven decision making

Senior leadership communication

Formation

MSc, MBA, PhD or equivalent

Outils

Monte Carlo simulations

Description du poste

Alnylam Pharmaceuticals seeks an experienced Vice President, Global Trial Optimization, to lead feasibility, protocol optimization, and patient recruitment across the development portfolio. You will drive scenario planning, enrollment modeling, and governance engagement to accelerate clinical development and improve trial performance.

You will lead a team supporting all trials, partnering across functions to design efficient studies using data-driven insights and patient-centered approaches