VP, Clinical Compliance & Systems — Strategy & Innovation

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 306,000 - 344,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. seeks a strategic Vice President to lead Clinical Compliance and Systems from Cambridge, MA. This newly created role will shape how Clinical Operations delivers compliant, scalable trial execution with strong governance and digital capabilities.

You will build and mentor a high-performing team, develop the long-term strategy, and partner across IT, Quality, and Development to enable data-driven decisions while ensuring inspection readiness and regulatory alignment.

Qualifications

• Bachelor’s degree in a scientific, healthcare, technology, business, or related discipline preferred.
• 15+ years of progressive experience within Clinical Operations, Clinical Quality/Compliance, Clinical Systems, or related functions in biotech/pharma.
• Significant leadership experience building, leading, and developing teams and organizational capabilities.
• Deep knowledge of clinical development, regulatory requirements (ICH-GCP, ICH E6(R3)), and trial execution.
• Ability to translate business and operational needs into scalable processes, systems, and technology solutions.
• Excellent communication and influencing skills with senior leaders across functions.

Responsibilities

• Provide strategic leadership and vision for Clinical Compliance and Clinical Systems within Clinical Operations, building scalable capabilities.
• Lead and mentor a high-performing team responsible for clinical compliance, TMF oversight, clinical systems, and related capabilities.
• Establish long-term strategy and roadmap for Clinical Compliance and Clinical Systems aligned with Clinical Operations priorities.
• Oversee clinical compliance activities for trials in accordance with regulations and internal standards.
• Maintain a robust framework for inspection readiness and audits across functions.
• Oversee eTMF/CTMS environments, processes, standards, and quality.
• Develop and implement governance for Clinical Systems to ensure data quality and cross-study visibility.
• Collaborate with IT on system selection, implementation, validation, and lifecycle management.
• Explore emerging technologies for digital innovation, automation, analytics, and AI in Clinical Operations.
• Support evolving operating models including internal, hybrid, FSP, and outsourced arrangements.
• Establish metrics and dashboards to assess compliance, systems performance, and risks.
• Plan for future needs as the portfolio grows and translate into scalable solutions.
• Contribute to the evolution of the function and build cross-functional relationships.
• Promote a culture of quality, collaboration, and patient focus.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Communication

Education

Bachelor's degree

Advanced degree preferred

Job description

Amylyx Pharmaceuticals, Inc. seeks a strategic Vice President to lead Clinical Compliance and Systems from Cambridge, MA. This newly created role will shape how Clinical Operations delivers compliant, scalable trial execution with strong governance and digital capabilities.

You will build and mentor a high-performing team, develop the long-term strategy, and partner across IT, Quality, and Development to enable data-driven decisions while ensuring inspection readiness and regulatory alignment.