Vice President, Clinical Compliance and Systems

Amylyx Pharmaceuticals, Cambridge, MA +1

The role

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.

Posted pay

$306K–$344K

a year

Compared with similar jobs

This base pay is above the median for director-level infrastructure, platform and SRE jobs in other US places.

Median: $225K a year
Other jobs in the group: 72

We compare the middle of each posted range. This is base pay as posted. The group does not include this job.

Location

Cambridge, MA +1

Work type

Not given

Level

Director+, manager

Experience

15+ years

Posted

Sep 28, 2026

Last check

10 h ago

Job type

Infra, platform & SRE

The role

What you will do

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.

Vice President, Clinical Compliance and Systems

The role

Vice President, Clinical Compliance and Systems

The role

What you will do

What you need

Work Location and Conditions

Estimated Pay Range

Pay and benefits

About Amylyx Pharmaceuticals

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Interview questions

Amylyx Pharmaceuticals

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