Senior Director, Clinical Systems

Scorpion Therapeutics; United States; Remote; USD 180,000 - 280,000; Full time

Benefits offered by this job

Remote-friendly role

Job summary

Amylyx is seeking a Senior Director, Clinical Systems to lead and optimize our clinical systems infrastructure to support expanding development programs. You will own CTMS implementation and governance, ensuring data integrity and regulatory compliance across platforms, while enabling study teams with scalable automation.

Remote-friendly role with periodic travel to Cambridge, MA. You will partner with IT, Quality, Clinical Operations and external vendors to build a high-performing Clinical

Qualifications

• 15+ years in clinical operations or biotech/pharma tech.
• Experience with CTMS and clinical platforms.
• Knowledge of GxP, 21 CFR Part 11, ICH guidelines.

Responsibilities

• Lead CTMS implementation and ongoing management.
• Establish governance and standards for clinical platforms.
• Drive automation and AI initiatives to modernize operations.
• Partner with IT, Quality, Clinical Operations and vendors; manage change and grow the Clinical Systems team.

Skills

Clinical systems leadership

CTMS implementation

GxP & 21 CFR Part 11

Project & change management

Education

Bachelor's in life sciences or related field

Tools

Veeva Vault

Medidata Rave

Job description

Role: Senior Director, Clinical Systems at Amylyx, responsible for developing and optimizing clinical systems infrastructure to support expanding clinical development activities. Responsibilities include leading the implementation and management of Clinical Trial Management System (CTMS), establishing governance and standards for clinical platforms, and driving automation and AI initiatives to modernize clinical operations.

The role involves partnering with IT, Quality, Clinical Operations, and vendors to ensure system compliance, data integrity, and effective study support, while managing change and building the Clinical Systems team.

Qualifications: Bachelor's in life sciences, information systems, or related; 15+ years in clinical operations, clinical systems, or biotech/pharma tech; expertise with clinical platforms such as CTMS, Veeva Vault, or Medidata Rave; knowledge of GxP, 21 CFR Part 11, ICH guidelines; strong project and change management skills.

High-Value: Focus on clinical trial technology within biopharma, supporting clinical phases, regulatory compliance, and data-driven decision-making, with remote work preferred and periodic travel to Cambridge, MA.

The role demands strategic thinking and hands-