Associate Director, Study Management
Alnylam Pharmaceuticals
August 21, 2026
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Summary of Key Responsibilities
- Accountable for delivery of operational strategy aligned with the Clinical Development Plan, including resourcing, budget, and change control; partner with CTWG and CDST on timeline creation.
- May chair and/or support Trial Leader in leading CTWG for execution of assigned trials.
- Develop and execute trial operational strategies and contribute to program-level planning with Director and cross-functional stakeholders.
- Lead operational scenario planning; mitigate risks impacting timelines/budget.
- Provide timely/quality oversight; escalate issues to Director, Quality, and functional leadership.
- Communicate and defend operational plan and costs at governance meetings as appropriate.
- Lead inspection readiness; build a knowledgeable, skilled clinical operations team.
- Promote cross-functional collaboration; set goals aligned with company/program/department goals.
- Ensure staff training; develop team performance through coaching and guidance.
- Represent Clinical Operations at CDST for early development programs.
- Interface with key internal stakeholders (e.g., Finance, Program/Vendor Management, Safety, Quality Assurance, Data Mgmt, Statistics, Regulatory, etc.).
- Lead/participate in process improvements; support Health Authority inspections and internal QA audits.
- Ability to travel ~10% average.
Qualifications
- BS/BA required.
- 8+ years clinical research experience (CRO/biotech/pharma) on Phase 1–4 global trials; at least 3 leading end-to-end global trials, including Phase 3 registrational trials.
- 2–5 years people leadership experience.
- Knowledge of pharmaceutical development process.
- Strong decision-making, analytical, and financial management skills; ability to manage all clinical trial execution aspects.
- Leadership, ability to foster productivity with limited supervision; leading without authority in matrix/global environments.
- Strong project planning, written/verbal communication, presentation, organizational, and problem-solving skills.
- Apply project management best practices; experience in novel clinical drug development.
- Proficient: MS Office (Excel, Word, PowerPoint) and MS Project.
Hybrid/Location
- Hybrid role, preferably Cambridge, MA or Philadelphia, PA (remote for exceptional candidates).
- Accountable for delivery of operational strategy aligned with the Clinical Development Plan, including resourcing, budget, and change control; partner with CTWG and CDST on timeline creation.
- May chair and/or support Trial Leader in leading CTWG for execution of assigned trials.
- Develop and execute trial operational strategies and contribute to program-level planning with Director and cross-functional stakeholders.
- Lead operational scenario planning; mitigate risks impacting timelines/budget.
- Provide timely/quality oversight; escalate issues to Director, Quality, and functional leadership.
- Communicate and defend operational plan and costs at governance meetings as appropriate.
- Lead inspection readiness; build a knowledgeable, skilled clinical operations team.
- Promote cross-functional collaboration; set goals aligned with company/program/department goals.
- Ensure staff training; develop team performance through coaching and guidance.
- Represent Clinical Operations at CDST for early development programs.
- Interface with key internal stakeholders (e.g., Finance, Program/Vendor Management, Safety, Quality Assurance, Data Mgmt, Statistics, Regulatory, etc.).
- Lead/participate in process improvements; support Health Authority inspections and internal QA audits.
- Ability to travel ~10% average.
Qualifications
- BS/BA required.
- 8+ years clinical research experience (CRO/biotech/pharma) on Phase 1–4 global trials; at least 3 leading end-to-end global trials, including Phase 3 registrational trials.
- 2–5 years people leadership experience.
- Knowledge of pharmaceutical development process.
- Strong decision-making, analytical, and financial management skills; ability to manage all clinical trial execution aspects.
- Leadership, ability to foster productivity with limited supervision; leading without authority in matrix/global environments.
- Strong project planning, written/verbal communication, presentation, organizational, and problem-solving skills.
- Apply project management best practices; experience in novel clinical drug development.
- Proficient: MS Office (Excel, Word, PowerPoint) and MS Project.
Hybrid/Location
- Hybrid role, preferably Cambridge, MA or Philadelphia, PA (remote for exceptional candidates).