Alnylam Pharmaceuticals
Associate Director, Clinical Operations
Alnylam Pharmaceuticals, Cambridge, Massachusetts, us, 02140
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 improve efficiency and effectiveness in 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 the day-to-day operational management activities of CROs.Manage strategic study operations including study sites, tracking systems for regulatory submissions, CRO KPIs, 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.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, and Medical Affairs.Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.Ability to travel (no more than annual average of 20%).Qualifications
Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.8+ years of clinical research experience with a Biotechnology or Pharmaceutical Company, specifically in later stage (Phase 2-4) multinational clinical studies.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.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.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.About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a new class of innovative medicines. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful approach to treating diseases at their genetic source. Since our founding in 2002, Alnylam has led the RNAi Revolution.Our Culture
Our people-first culture is guided by core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. Alnylam is proud to have been recognized as a top employer globally.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong and achieve their full potential.
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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 improve efficiency and effectiveness in 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 the day-to-day operational management activities of CROs.Manage strategic study operations including study sites, tracking systems for regulatory submissions, CRO KPIs, 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.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, and Medical Affairs.Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.Ability to travel (no more than annual average of 20%).Qualifications
Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.8+ years of clinical research experience with a Biotechnology or Pharmaceutical Company, specifically in later stage (Phase 2-4) multinational clinical studies.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.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.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.About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a new class of innovative medicines. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful approach to treating diseases at their genetic source. Since our founding in 2002, Alnylam has led the RNAi Revolution.Our Culture
Our people-first culture is guided by core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. Alnylam is proud to have been recognized as a top employer globally.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong and achieve their full potential.
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