Associate Director, Study Start Up
Alnylam, Cambridge, MA, United States
Associate Director, Study Start-Up
Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to join our dynamic and growing team. The Associate Director, Study Start-Up (SSU) provides tactical and operational leadership for assigned studies or programs, with accountability for delivery of end-to-end study start-up activities. This role drives start-up execution, ensures consistent application of SSU processes, and partners cross-functionally to proactively identify risks, resolve issues, and deliver predictable site activation timelines. The Associate Director supports implementation of SSU strategy and process standards while identifying risks, driving issue resolution, and contributing to continuous improvement initiatives. Key Responsibilities: Lead execution of end-to-end study start-up activities for assigned studies, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation. Drive early planning, risk identification, and proactive issue management to support delivery of study start-up timelines. Serve as escalation point for study-level start-up issues, ensuring timely resolution in partnership with cross-functional stakeholders. May provide people leadership for Study Start-Up Managers or SSU Leads, as needed. Ensure consistent application of SSU SOPs, work instructions, job aids, tools, and templates across assigned studies. Contribute to development, refinement, and rollout of SSU processes, tools, and training materials. Drive standardization and best-practice adoption across studies and regions. Monitor and report study-level SSU metrics and KPIs (e.g., site activation timelines, readiness-to-enroll). Use data and insights to identify risks, trends, and opportunities for improvement, escalating as appropriate. Ensure accurate maintenance and use of country and site intelligence to support study planning and execution. Partner with Study Start-up Leadership, Feasibility, Clinical Operations, Clinical Development, Regulatory, Legal, Finance, and CROs to ensure alignment and timely execution of start-up activities. Provide oversight of CRO performance related to study-level start-up deliverables. Support inspection readiness and ensure study start-up activities comply with ICH-GCP, global regulatory requirements, and internal policies and procedures. Participate in continuous improvement initiatives to improve efficiency, quality, and predictability of study start-up. Qualifications: Bachelor's degree in a healthcare, life sciences, or scientific discipline. Minimum of 8 years of experience in global clinical trial operations and/or study start-up. Minimum of 5 years of people leadership experience, including coaching, performance management, and development of direct reports. Strong understanding of global study start-up processes, regulatory pathways, and site activation models. Demonstrated ability to manage multiple priorities and deliver results in a matrixed environment. Strong analytical, problem-solving, and communication skills. Proven ability to partner cross-functionally and influence without authority. Working knowledge of ICH-GCP and the global regulatory environment. Experience leading complex, multi-regional studies. Experience contributing to process improvement, transformation, or optimization initiatives. Demonstrated success leading and retaining high-performing team members U.S. Pay Range $165,800.00 - $224,200.00
Alnylam Pharmaceuticals is seeking an Associate Director, Study Start-Up to join our dynamic and growing team. The Associate Director, Study Start-Up (SSU) provides tactical and operational leadership for assigned studies or programs, with accountability for delivery of end-to-end study start-up activities. This role drives start-up execution, ensures consistent application of SSU processes, and partners cross-functionally to proactively identify risks, resolve issues, and deliver predictable site activation timelines. The Associate Director supports implementation of SSU strategy and process standards while identifying risks, driving issue resolution, and contributing to continuous improvement initiatives. Key Responsibilities: Lead execution of end-to-end study start-up activities for assigned studies, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation. Drive early planning, risk identification, and proactive issue management to support delivery of study start-up timelines. Serve as escalation point for study-level start-up issues, ensuring timely resolution in partnership with cross-functional stakeholders. May provide people leadership for Study Start-Up Managers or SSU Leads, as needed. Ensure consistent application of SSU SOPs, work instructions, job aids, tools, and templates across assigned studies. Contribute to development, refinement, and rollout of SSU processes, tools, and training materials. Drive standardization and best-practice adoption across studies and regions. Monitor and report study-level SSU metrics and KPIs (e.g., site activation timelines, readiness-to-enroll). Use data and insights to identify risks, trends, and opportunities for improvement, escalating as appropriate. Ensure accurate maintenance and use of country and site intelligence to support study planning and execution. Partner with Study Start-up Leadership, Feasibility, Clinical Operations, Clinical Development, Regulatory, Legal, Finance, and CROs to ensure alignment and timely execution of start-up activities. Provide oversight of CRO performance related to study-level start-up deliverables. Support inspection readiness and ensure study start-up activities comply with ICH-GCP, global regulatory requirements, and internal policies and procedures. Participate in continuous improvement initiatives to improve efficiency, quality, and predictability of study start-up. Qualifications: Bachelor's degree in a healthcare, life sciences, or scientific discipline. Minimum of 8 years of experience in global clinical trial operations and/or study start-up. Minimum of 5 years of people leadership experience, including coaching, performance management, and development of direct reports. Strong understanding of global study start-up processes, regulatory pathways, and site activation models. Demonstrated ability to manage multiple priorities and deliver results in a matrixed environment. Strong analytical, problem-solving, and communication skills. Proven ability to partner cross-functionally and influence without authority. Working knowledge of ICH-GCP and the global regulatory environment. Experience leading complex, multi-regional studies. Experience contributing to process improvement, transformation, or optimization initiatives. Demonstrated success leading and retaining high-performing team members U.S. Pay Range $165,800.00 - $224,200.00