Vice President, Clinical Compliance and Systems

Amylyx Pharmaceuticals•Cambridge, MA

44d•$306,000 - $344,000•Remote

About The Position

Amylyx is seeking an experienced and strategic Vice President, Clinical Compliance & Systems to join our Clinical Operations leadership team. This newly created role will provide leadership and vision for two increasingly important capabilities within Clinical Operations: Clinical Compliance and Clinical Systems. In this role, “systems” refers to the operating model of Clinical Operations — the processes, governance, standards, tools, data practices, workflows, and oversight mechanisms, including the business use of clinical platforms, that support compliant, efficient, and scalable clinical trial execution. As Amylyx continues to advance and expand its clinical development portfolio, we are evolving our Clinical Operations model to build greater internal capability, strengthen oversight of clinical trial execution, and implement scalable processes and systems that enable high-quality, compliant, and data-driven decision making. The Vice President, Clinical Compliance & Systems will be responsible for establishing and advancing the strategy, infrastructure, processes, and capabilities required to support this evolution. The individual will oversee clinical compliance, inspection readiness, Trial Master File (TMF) strategy and governance, and the development and implementation of clinical systems and technologies supporting Clinical Operations. This leader will partner closely across Clinical Operations, Development Sciences, Quality, IT, and other functions to ensure Amylyx’s clinical operating infrastructure evolves with the needs of its programs and pipeline. This is an opportunity for a highly collaborative leader to build and shape a growing function, balancing strong compliance and operational discipline with innovation, agility, and fit-for-purpose solutions.

Requirements

Bachelor’s degree in a scientific, healthcare, technology, business, or related discipline required; advanced degree preferred.
Typically 15+ years of progressive experience within Clinical Operations, Clinical Quality/Compliance, Clinical Systems, or related functions within the biotechnology or pharmaceutical industry.
Significant leadership experience with responsibility for building, leading, and developing teams and organizational capabilities.
Deep knowledge of clinical development and clinical trial execution, including applicable global regulations, ICH-GCP requirements, and ICH E6(R3).
Demonstrated ability to translate business and operational needs into scalable processes, systems, and technology solutions.
Strong strategic thinking and judgment with the ability to balance regulatory requirements, operational needs, innovation, risk, and organizational priorities.
Excellent communication and influencing skills, with demonstrated ability to collaborate with senior leaders and stakeholders across scientific, operational, technical, and corporate functions.
Ability to operate effectively in a dynamic, fast-paced, entrepreneurial biotechnology environment and move comfortably between strategy and hands-on execution.
Demonstrated commitment to developing people, building strong teams, and creating an inclusive and collaborative working environment.

Responsibilities

Provide strategic leadership and vision for the Clinical Compliance and Clinical Systems functions within Clinical Operations, establishing scalable capabilities to support Amylyx’s clinical portfolio.
Build, lead, develop, and mentor a high-performing team responsible for clinical compliance, TMF oversight, clinical systems, and related capabilities.
Establish the long-term strategy and roadmap for Clinical Compliance and Clinical Systems, ensuring investments are appropriately sequenced and aligned with Clinical Operations and broader Development priorities.
Provide leadership for clinical compliance activities supporting the execution of Amylyx-sponsored clinical trials in accordance with applicable regulations, ICH-GCP requirements, internal standards, and industry best practices.
Establish and maintain a robust framework for inspection readiness, partnering across functions to ensure ongoing preparedness for regulatory inspections and audits.
Provide strategic oversight and governance of Amylyx’s electronic Trial Master File (eTMF) environment, including processes, standards, quality, completeness, and inspection readiness.
Partner with Clinical Operations and cross-functional stakeholders to evolve and modernize clinical processes, SOPs, work instructions, templates, and supporting tools, including implementation of requirements associated with evolving regulatory standards such as ICH E6(R3).
Develop and execute a comprehensive business capability roadmap for clinical and data-enabled operations, identifying the technology-enabled capabilities required to support efficient, scalable, and compliant clinical trial execution.
Lead the evolution of clinical technology infrastructure, including eTMF, Clinical Trial Management System (CTMS), reporting and dashboard capabilities, and other Clinical platforms and tools.
In partnership with other cross functional stakeholders, establish appropriate governance, ownership, standards, and processes across Clinical Systems to promote data quality, consistency, usability, and effective cross-study visibility.
Partner closely with IT and other stakeholders on system selection, implementation, integration, validation, security, change management, and ongoing lifecycle management.
Evaluate emerging technologies and opportunities for digital innovation, automation, analytics, and responsible use of AI within Clinical Operations.
Partner with Clinical Business Operations, Global Site Services, Clinical Program and Study teams, and other Clinical Operations leaders to support Amylyx’s evolving mix of internal, hybrid, FSP, and outsourced operating models.
Establish meaningful metrics, dashboards, and other mechanisms to assess compliance, system performance, operational effectiveness, risks, and opportunities for continuous improvement.
Anticipate future organizational and infrastructure needs as the clinical portfolio grows and translate those needs into thoughtful, scalable solutions.
Serve as a senior Clinical Operations leader and trusted advisor, contributing broadly to the evolution of the function and fostering strong cross-functional relationships throughout the organization.
Promote a culture of quality, collaboration, innovation, continuous improvement, and patient focus.