Associate Director, Clinical Operations

Alnylam Pharmaceuticals - Cambridge, MA

Full-time - Mid Level

Cambridge, MA

Chemical Manufacturing

About the position

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%.

Responsibilities

• Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources.
• Manage performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving.
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
• Provide leadership and input into global subject/patient recruitment plans.
• Effectively communicate and interact with Key Opinion Leaders.
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and day-to-day operational management activities of CROs.
• Develop Key Performance Indicators (KPIs) and manage global resources, expertise, and knowledge within the CRO/vendor.
• Manage strategic study operations including study sites, tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budgetary and financial information, and performance metrics.
• Participate in Case Report Form design and user acceptance testing in partnership with data management.
• Generate country specific Informed Consent Form(s).
• Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
• Provide support to clinical trial managers within and/or across programs.
• Prepare budgets, timelines, and forecasts for clinical studies.
• Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs; which may include leading sub-teams and/or acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.

Requirements

• Bachelor's Degree is required; an advanced degree in a scientific and/or business/finance discipline is preferred.
• 8+ years of clinical research experience gained with a Biotechnology or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies.
• Experience in rare diseases and/or difficult to recruit patient populations preferred.
• 2+ years clinical project management experience with global clinical studies.
• Proven experience in effectively leading teams and managing direct reports.
• Strong regulatory knowledge, including Good Clinical Practices (GCPs).
• Exceptional organizational skills and ability to deal with competing priorities, along with strong reasoning and problem-solving ability.
• Excellent communication (written and verbal) and presentation skills along with leadership qualities.
• Knowledge of global clinical trial management in a fast-paced CRO outsourced environment.
• Ability to assemble a plan and execute on the details.
• Apply project management best practices to programs; experience in novel clinical drug development.
• Experience with protocol, ICF, CRF, CSR development and review.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.

Nice-to-haves

• Experience in rare diseases and/or difficult to recruit patient populations preferred.