Alnylam Pharmaceuticals - Cambridge, MA
posted 4 months ago
The Associate Director of Clinical Operations at Alnylam Pharmaceuticals plays a pivotal role in leading and managing the integration of all project team activities. This position requires leveraging both internal and development partner resources, as well as optimizing the expertise and knowledge of Contract Research Organizations (CROs). The Associate Director will be responsible for managing the performance, development, and growth of junior staff, guiding them towards improved efficiency and effectiveness in prioritization and problem-solving. This role demands a highly experienced line manager who can provide strategic input and execution of clinical trials, from protocol design to the final clinical study report for specified studies. In addition to overseeing clinical trials, the Associate Director will provide leadership and input into global subject and patient recruitment plans, ensuring effective communication and interaction with Key Opinion Leaders. The role also involves managing all aspects of CRO/vendor identification, including the submission of requests for proposals, CRO selection, and the day-to-day operational management activities of CROs. This includes developing Key Performance Indicators (KPIs) and managing global resources and expertise within the CRO/vendor framework. The Associate Director will be tasked with managing strategic study operations, which encompass study sites, tracking systems for regulatory submissions, drug supply and use, subject enrollment, regulatory document flow, study timelines, budgetary and financial information, and performance metrics. Participation in Case Report Form design and user acceptance testing in partnership with data management is also a key responsibility. The role requires generating country-specific Informed Consent Forms and leading the development of contingency and risk management plans for projects. Additionally, the Associate Director will assist the Director/Senior Director of Clinical Operations in preparing and executing sound development strategies, providing support to clinical trial managers across programs, and preparing budgets, timelines, and forecasts for clinical studies. Collaboration with various departments such as Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, and Medical Affairs is essential, which may include leading sub-teams and acting as a liaison between groups. The Associate Director will also provide variance analysis of budget to actual expenditures and notify finance of projected cost over or under expenditure. The position requires the ability to travel, with an expectation of no more than an annual average of 20%.