Alnylam Pharmaceuticals
Associate Director, Clinical Operations
Alnylam Pharmaceuticals, Cambridge, Massachusetts, us, 02140
The Associate Director, Clinical Operations is responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning.
Summary of Key Responsibilities
Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences. Partners directly with or guides staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol and study designs and other key study and program/project deliverables. Participates in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provides direction to junior staff to manage the process, as necessary. Effectively discusses and represents study data across the company; collaborates with medical writers and investigators to write, publish and present data. Develops tracking tools and oversees project budgets, study timelines, and deliverables. Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor. Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc. Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects. Identifies and reports potential program/project issues and resource deficiencies effectively and in a timely manner and implements corrective action. Organizes logistics and partners with supply operations to manage clinical trial product supply and labeling of study drug as required by the clinical program/project. Assists in the development of global department standards and successful implementation of process improvements and change. May manage performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving; highly experienced as a line manager. May be required to represent Clinical Operations on cross-functional partner teams. Qualifications
Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred. 8+ years previous experience gained with a CRO or pharmaceutical company working on multinational clinical studies. 6+ years managing clinical studies and direct reports. Proven track record in resource planning forecasting, and budgeting. Previous experience participating in a NDA/BLA is preferred. Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs). Good organizational skills and ability to deal with competing priorities. Strong communication skills (written, verbal and presentation). Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project. Experience with Visio, Veeva systems and/or PleaseReview is a plus. Strategic Thinking: General knowledge of all major aspects of drug discovery and development to be an effective problem solver for complex problems. Scientific Understanding: Thorough understanding of therapeutic mechanisms of focus and current scientific developments within his/her area of expertise to provide recommendations on both project and disease area levels. Clear alignment with Alnylam's Core Values: Commitment to People Innovation and Discovery Sense of Urgency Open Culture Passion for Excellence About Alnylam:
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our culture:
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others. 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, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
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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, expertise and knowledge. Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences. Partners directly with or guides staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol and study designs and other key study and program/project deliverables. Participates in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provides direction to junior staff to manage the process, as necessary. Effectively discusses and represents study data across the company; collaborates with medical writers and investigators to write, publish and present data. Develops tracking tools and oversees project budgets, study timelines, and deliverables. Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor. Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc. Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects. Identifies and reports potential program/project issues and resource deficiencies effectively and in a timely manner and implements corrective action. Organizes logistics and partners with supply operations to manage clinical trial product supply and labeling of study drug as required by the clinical program/project. Assists in the development of global department standards and successful implementation of process improvements and change. May manage performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving; highly experienced as a line manager. May be required to represent Clinical Operations on cross-functional partner teams. Qualifications
Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred. 8+ years previous experience gained with a CRO or pharmaceutical company working on multinational clinical studies. 6+ years managing clinical studies and direct reports. Proven track record in resource planning forecasting, and budgeting. Previous experience participating in a NDA/BLA is preferred. Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs). Good organizational skills and ability to deal with competing priorities. Strong communication skills (written, verbal and presentation). Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project. Experience with Visio, Veeva systems and/or PleaseReview is a plus. Strategic Thinking: General knowledge of all major aspects of drug discovery and development to be an effective problem solver for complex problems. Scientific Understanding: Thorough understanding of therapeutic mechanisms of focus and current scientific developments within his/her area of expertise to provide recommendations on both project and disease area levels. Clear alignment with Alnylam's Core Values: Commitment to People Innovation and Discovery Sense of Urgency Open Culture Passion for Excellence About Alnylam:
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our culture:
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others. 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, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
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