Vice President, Global Trial Optimization
Alnylam Pharmaceuticals
20 days ago
Remote friendly (Cambridge, MA)
United States
$301,800 - $408,200 USD yearly
Clinical Research and Development
Overview
The Vice President, Global Trial Optimization leads strategic feasibility, protocol optimization, and scenario planning to inform clinical trial design with data-driven, efficient delivery plans, including patient recruitment and retention strategies and patient/site experience. Accountable for strategic feasibility and scenario planning, protocol optimization, site identification, recruitment/retention, patient/site experience, and people management.
Key Responsibilities
- Drive a Feasibility Center of Excellence and partner with preferred CROs on data-driven clinical trial scenario plans for country placement, enrollment rates, and timelines; design feasibility tools/processes.
- Lead country placement discussions and provide recommendations; represent Clinical Operations at governance forums.
- Lead protocol feasibility and scenario modeling; recommend optimized delivery strategies for country/site placement, enrollment rates, site identification, and milestones.
- Oversee enrollment modeling; assess impact of inclusion/exclusion criteria on enrollment potential and timelines.
- Partner with study teams/CROs on study timeline, milestone, and enrollment assumptions; lead CLOCK reviews and communicate CLOCK milestones.
- Facilitate site identification and define best-fit site archetype.
- Own predictable recruitment & retention delivery; lead portfolio-level recruitment strategies/sourcing focused on reduced patient burden and appropriate diversity.
- Estimate recruitment program impact on enrollment and cost.
- Identify/analyze connections within/across therapeutic areas to optimize portfolio planning and performance.
Qualifications
- MSc/MBA/PhD or equivalent strongly preferred.
- 20+ years clinical operations experience (global trials, feasibility, protocol optimization, recruitment/retention, global CROs).
- 10+ years team leadership.
- Deep feasibility/scenario planning knowledge; experience with supportive tools/technologies and Monte Carlo simulations; strong data analysis/interpretation.
- Knowledge of feasibility, protocol optimization, site identification, recruitment/retention processes.
- Extensive patient recruitment campaign experience.
- Demonstrated delivery within budget/timeline; cost optimization/reduction experience.
- Extensive pharma/biotech drug development knowledge, ICH-GCP, 21 CFR Part 11, and health authority regulations.
- Comfortable with senior executive teams; strong project management/matrix leadership; travel up to 30%.
The Vice President, Global Trial Optimization leads strategic feasibility, protocol optimization, and scenario planning to inform clinical trial design with data-driven, efficient delivery plans, including patient recruitment and retention strategies and patient/site experience. Accountable for strategic feasibility and scenario planning, protocol optimization, site identification, recruitment/retention, patient/site experience, and people management.
Key Responsibilities
- Drive a Feasibility Center of Excellence and partner with preferred CROs on data-driven clinical trial scenario plans for country placement, enrollment rates, and timelines; design feasibility tools/processes.
- Lead country placement discussions and provide recommendations; represent Clinical Operations at governance forums.
- Lead protocol feasibility and scenario modeling; recommend optimized delivery strategies for country/site placement, enrollment rates, site identification, and milestones.
- Oversee enrollment modeling; assess impact of inclusion/exclusion criteria on enrollment potential and timelines.
- Partner with study teams/CROs on study timeline, milestone, and enrollment assumptions; lead CLOCK reviews and communicate CLOCK milestones.
- Facilitate site identification and define best-fit site archetype.
- Own predictable recruitment & retention delivery; lead portfolio-level recruitment strategies/sourcing focused on reduced patient burden and appropriate diversity.
- Estimate recruitment program impact on enrollment and cost.
- Identify/analyze connections within/across therapeutic areas to optimize portfolio planning and performance.
Qualifications
- MSc/MBA/PhD or equivalent strongly preferred.
- 20+ years clinical operations experience (global trials, feasibility, protocol optimization, recruitment/retention, global CROs).
- 10+ years team leadership.
- Deep feasibility/scenario planning knowledge; experience with supportive tools/technologies and Monte Carlo simulations; strong data analysis/interpretation.
- Knowledge of feasibility, protocol optimization, site identification, recruitment/retention processes.
- Extensive patient recruitment campaign experience.
- Demonstrated delivery within budget/timeline; cost optimization/reduction experience.
- Extensive pharma/biotech drug development knowledge, ICH-GCP, 21 CFR Part 11, and health authority regulations.
- Comfortable with senior executive teams; strong project management/matrix leadership; travel up to 30%.