Director, Study Start Up

Provide oversight of end-to-end study start-up activities, including site feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation. Ensure early planning, risk identification, and timely decision-making to support predictable study start-up timelines. Serve as the escalation point for study start-up issues, ensuring timely resolution and minimal impact to delivery. Lead resourcing, hiring, performance management, and talent development for SSU Leads and/or Managers. Establish clear expectations, accountability, and development plans aligned with Alnylam leadership behaviors. Lead development, implementation, and training of SSU SOPs, work instructions, job aids, tools, and templates in partnership with the Head of Study Start-Up. Drive standardization and consistent execution of study start-up processes across therapeutic areas and regions. Lead continuous improvement initiatives focused on reducing cycle time, cost, and operational burden. Monitor, analyze, and report SSU performance metrics and KPIs (e.g., site activation timelines, readiness-to-enroll). Leverage data-driven insights to drive accountability, forecast performance, and inform portfolio-level decision-making. Ensure maintenance and effective use of country and site intelligence to support study start-up strategy and planning. Partner with the Feasibility Center of Excellence, Clinical Operations, Clinical Development, Regulatory, Legal, Finance, and CROs to facilitate cross-functional alignment and execution. Represent SSU in governance forums, providing clear, data-driven updates, risks, and recommendations. Provide oversight and performance management of CRO partners related to study start-up deliverables. Ensure study start-up activities comply with ICH-GCP, global regulatory requirements, and internal policies and procedures. Support inspection readiness and quality initiatives related to study start-up activities. Bachelor's degree required; degree in Life Sciences, Healthcare, or a scientific discipline preferred. Advanced degree (e.g., Master's, MBA, MPH) preferred. 10+ years of experience in global clinical trial operations and/or study start-up, including complex, multi-regional clinical trials. 7+ years of people leadership experience, including leading managers and/or senior-level individual contributors. Demonstrated success providing strategic oversight of end-to-end study start-up activities, from feasibility through site activation. Proven experience leading complex, cross-functional study start-up initiatives with strong project management discipline, including planning, sequencing, risk management, and delivery against timelines. Experience driving early planning, risk identification, and issue resolution to deliver predictable study timelines. Experience leading development and implementation of SOPs, work instructions, tools, and standardized processes in a regulated environment. Strong experience overseeing CRO partners and vendors, including performance management, issue escalation, and accountability against contracted deliverables and KPIs. Demonstrated ability to operate effectively in a matrixed, global organization with multiple stakeholders. Experience supporting inspections and ensuring compliance with global regulatory requirements. Deep understanding of global study start-up processes, including feasibility, site selection, regulatory and ethics submissions, site contracting, and site activation. Advanced working knowledge of ICH-GCP and the global regulatory environment. Strong project management skills, including development and management of integrated plans, dependency mapping, risk mitigation, and issue resolution across cross-functional teams. Proven vendor management skills, including CRO oversight, performance monitoring, governance participation, and driving corrective actions when required. Strong leadership and people management skills, including talent development, performance management, and succession planning. Proven ability to influence and align cross-functional stakeholders and drive accountability without direct authority. Strong analytical and critical-thinking skills, with the ability to interpret data, identify trends, and make sound, data-driven decisions. Demonstrated experience using metrics and KPIs to monitor performance, forecast outcomes, and drive continuous improvement. Excellent written and verbal communication skills, with the ability to present clear, concise, and persuasive information to senior leadership. Strong problem-solving skills with the ability to manage complexity and competing priorities in a fast-paced environment. Experience with clinical trial systems and tools (e.g., CTMS, eTMF, IRT, eCOA). High level of business acumen, including understanding of cost drivers, resource planning, and operational trade-offs