VP, Clinical Compliance & Systems Leader

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); À distance; USD 306 000 - 344 000; Plein temps

Avantages offerts par ce poste

Remote work within the U.S.

Travel to Cambridge, MA as needed

Résumé du poste

Amylyx Pharmaceuticals, Inc. is seeking a strategic leader to drive Clinical Compliance and Clinical Systems within Clinical Operations. This role oversees TMF governance, inspection readiness, and the deployment of CTMS and other clinical platforms, ensuring compliant, scalable trial execution.

The VP will partner across functions to evolve processes, governance, and technology in a dynamic biotech environment, building a high-performing team and guiding cross-functional initiatives.

Qualifications

• Bachelor's degree in a scientific, healthcare, technology, business, or related discipline required; advanced degree preferred.
• 15+ years in Clinical Operations, Clinical Quality/Compliance, or Clinical Systems within biotech/pharma.

Responsabilités

• Provide strategic leadership for Clinical Compliance and Clinical Systems within Clinical Operations.
• Build and mentor a high-performing team for compliance, TMF, and clinical systems.
• Develop long-term strategy and roadmap for compliance and systems in Clinical Operations.
• Ensure execution of trials in accordance with regulations (ICH-GCP) and internal standards.
• Oversee inspection readiness and eTMF governance and lifecycle management.
• Modernize clinical processes, SOPs, templates, and supporting tools.
• Lead governance and data quality initiatives across Clinical Systems.

Connaissances

Clinical Operations leadership

Regulatory knowledge

ICH-GCP

Strategic thinking

Communication

Formation

Bachelor's degree in science/health/tech/business

Advanced degree preferred

Outils

eTMF

CTMS

Data dashboards

Description du poste

Amylyx Pharmaceuticals, Inc. is seeking a strategic leader to drive Clinical Compliance and Clinical Systems within Clinical Operations. This role oversees TMF governance, inspection readiness, and the deployment of CTMS and other clinical platforms, ensuring compliant, scalable trial execution.

The VP will partner across functions to evolve processes, governance, and technology in a dynamic biotech environment, building a high-performing team and guiding cross-functional initiatives.