Vice President, Clinical Compliance and Systems

The role

This leader will provide strategic leadership and vision for Clinical Compliance and Clinical Systems within Clinical Operations. The role involves establishing infrastructure, processes, and capabilities to support clinical trial execution and scalable decision making.

What you will do

• Provide strategic leadership and vision for Clinical Compliance and Clinical Systems functions
• Build, lead, develop, and mentor a high-performing team
• Establish the long-term strategy and roadmap for Clinical Compliance and Clinical Systems
• Provide leadership for clinical compliance activities in accordance with regulations and ICH-GCP
• Establish and maintain a framework for inspection readiness
• Provide strategic oversight and governance of the electronic Trial Master File environment
• Partner with stakeholders to evolve clinical processes, SOPs, and tools
• Develop and execute a business capability roadmap for clinical and data-enabled operations
• Lead the evolution of clinical technology infrastructure including eTMF and CTMS
• Establish metrics and dashboards to assess compliance and system performance

Required qualifications

• Bachelor’s degree in a scientific, healthcare, technology, business, or related discipline
• 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
• Excellent communication and influencing skills
• Ability to operate effectively in a dynamic, fast-paced, entrepreneurial biotechnology environment
• Demonstrated commitment to developing people and building strong teams
• Access to a work setting that enables meeting all role requirements including privacy and reliable internet

Nice to have

• Advanced degree

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside in Alaska or Hawaii
• Must have access to a work setting that enables meeting all requirements of the role

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs through rigorous science.