The Opportunity

Amylyx is seeking an experienced and innovative Senior Director, Clinical Systems to join our Clinical Operations organization. This newly created role will be responsible for advancing clinical systems capabilities needed to support Amylyx’s evolving clinical development portfolio, in collaboration with Information Technology, Quality and other functions.

As Amylyx expands its internal Clinical Operations capabilities to accommodate a variety of outsourced operating models, our clinical technology and internal working procedures must evolve to support this shift. The Senior Director, Clinical Systems will partner with IT and Clinical Operations, playing a critical role in defining the systems, tools, data, and processes that enable efficient, compliant, and data-driven clinical trial execution.

Reporting to the Vice President, Clinical Compliance & Systems, this individual will partner with IT and Clinical Operations to translate strategy and business needs into a scalable clinical systems roadmap. The role will initially have significant focus on enabling CTMS capabilities, improved cross-study reporting and visibility, and development of the comprehensive operational ecosystem required to support these processes and systems over time. This individual will also partner with Information Delivery to identify opportunities to evolve process through use of AI and other automation/analytic platforms.

This is an opportunity for a hands-on, forward-thinking clinical leader who enjoys building capabilities, solving complex operational challenges, and identifying thoughtful ways to use technology, automation, analytics, and emerging tools to improve how clinical development work gets done.

Responsibilities

• Own the operational development and ongoing business management of Amylyx’s Clinical Systems ecosystem in partnership with the Vice President, Clinical Compliance & Systems, IT and key cross-functional stakeholders, translating Clinical Operations priorities and business requirements into a practical, scalable clinical systems roadmap that supports current programs and future portfolio growth. Partner cross functionally to develop plans and achieve objectives.
• Lead the operational implementation and ongoing optimization of a Clinical Trial Management System (CTMS) to provide greater visibility into study execution, milestones, operational performance, and portfolio-level activities. Define Key performance indicators to enhance clinical reporting, dashboards, and analytics capabilities, providing Clinical Operations leaders and study teams with meaningful, timely visibility across programs and studies.
• Establish effective operational system governance, standards, business processes, roles, and responsibilities to promote consistent and effective use of clinical platforms across studies, as well as data quality.
• In conjunction with Information Delivery, identify and evaluate opportunities to leverage automation, digital tools, analytics, and responsible applications of AI to modernize Clinical Operations procedures and improve efficiency and decision making through technology and workflow improvement.
• Partner with Clinical Compliance and Records to ensure clinical systems and associated processes support regulatory requirements, data integrity, inspection readiness, and applicable quality standards.
• Partner closely with IT, Quality, Clinical Business Operations, and other stakeholders to evaluate new clinical technologies. Provide business-focused leadership for system selection in alignment with Amylyx’ internal process.
• Partner with Clinical Program/Study Teams to understand technology requirements in Amylyx’s Clinical Studies. Partner with IT to identify suitable vendors and solutions to support clinical study technology requirements, and provide expertise and guidance to ensure technology plans and platforms support study goals.
• Ensure effective quality oversight of technology deployed in clinical trials such as ePRO, eCOA, decentralized data collection tools, etc., including system oversight activities such as UAT and periodic review, and partner with Study Team members in vendor oversight activities such as review of Quality Events, Change Controls, etc.
• Lead change management and adoption efforts associated with new Clinical Operations systems and capabilities, ensuring teams understand not only how to use new tools but how they support more effective ways of working. Own ongoing change impact assessments and manage Change activities in accordance with computer system / Quality Change SOPs.
• Build and develop the Clinical Systems organization within Clinical Operations as needs evolve, including oversight and development of internal team members, consultants, and external partners.
• Stay current on emerging clinical technologies, industry trends, regulatory expectations, and best practices and recommend opportunities relevant to Amylyx’s clinical development model.

Qualifications

• Bachelor’s degree in life sciences, information systems, technology, business, or a related discipline required; advanced degree preferred.
• Typically 15+ years of progressive experience in Clinical Operations, Clinical process development, Clinical Systems, clinical technology, or related areas within the biotechnology or pharmaceutical industry.
• Demonstrated expertise with clinical platforms, including experience leading system implementations from an operational perspective including requirements definition and vendor evaluation through deployment, adoption, and optimization.
• Prior experience leading and managing CTMS and other clinical platform implementations is required. Familiarity with Veeva Vault and Medidata Rave clinical solutions preferred.
• Knowledge of applicable clinical trial process, regulatory and quality requirements, including ICH-GCP, ICH E6(R3), 21 CFR Part 11, data integrity principles, and expectations for validated systems.
• Strong project and change management capabilities, including the ability to manage multiple complex initiatives simultaneously.
• Excellent communication, collaboration, and problem-solving skills, with the ability to communicate effectively with both technical and non-technical stakeholders.
• Ability to thrive in a dynamic biotechnology environment and operate effectively at both the strategic and hands-on execution levels.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.