Vice President, Global Trial Optimization
Alnylam Pharmaceuticals
5 hours ago
Remote friendly (Cambridge, MA)
United States
$301,800 - $408,200 USD yearly
Clinical Research and Development
Key Responsibilities:
- Drive a Feasibility Center of Excellence and partner with CROs to deliver data-driven clinical trial scenario plans for country placement, enrollment rates, and study timelines; design and develop feasibility tools/processes.
- Lead country placement discussions and provide recommendations supporting business and trial needs; represent Clinical Operations at governance forums (e.g., DevBoard, DOC, PLT).
- Lead protocol feasibility and scenario modeling; recommend optimized trial delivery strategies for country/site placement, enrollment rates, site identification, and trial milestones.
- Oversee enrollment modeling; model impact of inclusion/exclusion criteria on enrollment potential and timelines.
- Partner with study teams/CROs to provide data-driven timelines, milestones, and enrollment assumptions; lead CLOCK reviews and communicate CLOCK milestones.
- Facilitate site identification and define best-fit site archetypes.
- Accountable for predictable patient recruitment and retention strategy delivery; lead portfolio recruitment strategy/sourcing focused on reduced patient burden and diversity where appropriate.
- Estimate impacts of recruitment programs on trial enrollment and cost.
- Identify/analyze connections within/across therapeutic areas to optimize portfolio study planning and performance.
Qualifications:
- MSc, MBA, PhD, or equivalent in relevant discipline (strongly preferred).
- 20+ years industry experience in Clinical Operations, including global trial conduct, feasibility, protocol optimization, patient recruitment/retention, and working with global CROs.
- 10+ years team leadership building feasibility and patient recruitment teams.
- Deep knowledge of feasibility and scenario planning; experience with feasibility tools/technologies, Monte Carlo simulations; strong data analysis/interpretation.
- Thorough understanding of feasibility, protocol optimization, site identification, and patient recruitment/retention processes.
- Extensive patient recruitment campaign experience.
- Proven ability to deliver results within budget/timeline; cost optimization/reduction experience.
- Knowledge of drug development processes, ICH-GCP, 21 CFR Part 11, and major Health Authority regulations.
- Comfortable working with senior executive teams; strong industry network.
- Strong project management and matrix leadership; holds teams accountable.
- Ability to travel up to 30%.
U.S. Pay Range (base): $301,800.00 - $408,200.00; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
Benefits: medical/dental/vision; life/disability; lifestyle reimbursement; flexible spending/health savings; 401(k) match; paid time off, wellness days, holidays, recharge breaks; family resources/leave.
- Drive a Feasibility Center of Excellence and partner with CROs to deliver data-driven clinical trial scenario plans for country placement, enrollment rates, and study timelines; design and develop feasibility tools/processes.
- Lead country placement discussions and provide recommendations supporting business and trial needs; represent Clinical Operations at governance forums (e.g., DevBoard, DOC, PLT).
- Lead protocol feasibility and scenario modeling; recommend optimized trial delivery strategies for country/site placement, enrollment rates, site identification, and trial milestones.
- Oversee enrollment modeling; model impact of inclusion/exclusion criteria on enrollment potential and timelines.
- Partner with study teams/CROs to provide data-driven timelines, milestones, and enrollment assumptions; lead CLOCK reviews and communicate CLOCK milestones.
- Facilitate site identification and define best-fit site archetypes.
- Accountable for predictable patient recruitment and retention strategy delivery; lead portfolio recruitment strategy/sourcing focused on reduced patient burden and diversity where appropriate.
- Estimate impacts of recruitment programs on trial enrollment and cost.
- Identify/analyze connections within/across therapeutic areas to optimize portfolio study planning and performance.
Qualifications:
- MSc, MBA, PhD, or equivalent in relevant discipline (strongly preferred).
- 20+ years industry experience in Clinical Operations, including global trial conduct, feasibility, protocol optimization, patient recruitment/retention, and working with global CROs.
- 10+ years team leadership building feasibility and patient recruitment teams.
- Deep knowledge of feasibility and scenario planning; experience with feasibility tools/technologies, Monte Carlo simulations; strong data analysis/interpretation.
- Thorough understanding of feasibility, protocol optimization, site identification, and patient recruitment/retention processes.
- Extensive patient recruitment campaign experience.
- Proven ability to deliver results within budget/timeline; cost optimization/reduction experience.
- Knowledge of drug development processes, ICH-GCP, 21 CFR Part 11, and major Health Authority regulations.
- Comfortable working with senior executive teams; strong industry network.
- Strong project management and matrix leadership; holds teams accountable.
- Ability to travel up to 30%.
U.S. Pay Range (base): $301,800.00 - $408,200.00; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
Benefits: medical/dental/vision; life/disability; lifestyle reimbursement; flexible spending/health savings; 401(k) match; paid time off, wellness days, holidays, recharge breaks; family resources/leave.