Senior Director, Clinical Systems

The role

The Senior Director, Clinical Systems will advance clinical systems capabilities to support the clinical development portfolio. This role involves partnering with IT and Clinical Operations to define systems, tools, data, and processes for clinical trial execution.

What you will do

• Own the operational development and business management of the Clinical Systems ecosystem
• Lead the implementation and optimization of a Clinical Trial Management System (CTMS)
• Define Key performance indicators to enhance clinical reporting and analytics
• Establish operational system governance, standards, and business processes
• Identify opportunities to leverage automation, digital tools, and AI
• Partner with Clinical Compliance and Records to ensure regulatory and data integrity compliance
• Evaluate new clinical technologies and provide leadership for system selection
• Partner with Clinical Program/Study Teams to understand technology requirements
• Ensure quality oversight of technology deployed in clinical trials
• Lead change management and adoption efforts for new systems

Required qualifications

• Bachelor’s degree in life sciences, information systems, technology, business, or a related discipline
• 15+ years of progressive experience in Clinical Operations, Clinical process development, Clinical Systems, clinical technology, or related areas within the biotechnology or pharmaceutical industry
• Expertise with clinical platforms including leading system implementations from requirements to optimization
• Experience leading and managing CTMS and other clinical platform implementations
• Knowledge of clinical trial process, regulatory and quality requirements, including ICH-GCP, ICH E6(R3), 21 CFR Part 11, data integrity principles, and expectations for validated systems
• Strong project and change management capabilities
• Excellent communication, collaboration, and problem-solving skills
• Ability to thrive in a dynamic biotechnology environment and operate at strategic and hands-on levels

Nice to have

• Advanced degree
• Familiarity with Veeva Vault and Medidata Rave clinical solutions

Benefits

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

Before you apply

• Unable to hire employees who reside and/or work in Alaska and Hawaii
• Must have access to a work setting that enables meeting all role requirements including privacy and reliable internet

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.