Director, Global Clinical Operations & Delivery

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remote; USD 200,000 - 235,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Director, Clinical Operations to lead end-to-end global trials, translating strategy into executable plans and ensuring timelines, budget, quality, and compliance.

The role requires extensive CRO/vendor management, GCP/ICH/FDA knowledge, and strong leadership. This position supports remote work within the US with travel to Cambridge, MA and occasional international travel.

Qualifications

• BS/BA Degree in science or a health-related field preferred.
• Minimum of 12 years of clinical operations experience in pharma/biotech and/or CRO setting.
• Experience and understanding of global clinical trial operations; study startup through close-out; strong vendor management; inspection-ready mindset.
• Effective project management with ability to provide critical insight and analytical problem-solving.
• Experience with Remote Data Acquisition tools and decentralized study requirements; comfortable with tech deployment in trials.
• Ability to manage competing priorities, detail-oriented, multi-tasking.
• Excellent knowledge of GCP, ICH and FDA regulations/guidances.
• Willingness to travel up to 20%, primarily domestic; potential for international travel.
• Therapeutic experience in rare diseases, Endocrinology or CNS conditions preferred.

Responsibilities

• Provide end-to-end operational leadership for global clinical trials across full study lifecycles.
• Oversee study operational plans: timelines, enrollment assumptions, resources, dependencies, risks and contingencies.
• Drive execution against milestones, identify risks and mitigations.
• Ensure compliant procedures for high-quality trial data and operational excellence.
• Develop, analyze, and report metrics for clinical programs.
• Collaborate with leadership to meet deliverables on time and within budget.
• Contribute to study documentation (protocols, manuals, ICFs, CRFs, SSRS).
• Communicate trial status and lessons learned to cross-functional stakeholders and senior leadership.
• Manage CRO/vendor selection and contracting, and oversee outsourcing strategies and financial reporting.
• Foster relationships with CROs, vendors, investigators, and external partners.
• Address vendor performance issues and develop mitigation strategies.
• Develop SOPs and standardized forms for Clinical Operations processes.
• Provide leadership and mentorship to direct reports where applicable.

Skills

Global clinical trials leadership

Vendor management

Regulatory compliance (GCP/ICH/FDA)

Project management

Risk assessment and mitigation

Communication skills

Education

BS/BA Degree in science or health-related field

Job description

Amylyx Pharmaceuticals, Inc. is seeking a Director, Clinical Operations to lead end-to-end global trials, translating strategy into executable plans and ensuring timelines, budget, quality, and compliance.

The role requires extensive CRO/vendor management, GCP/ICH/FDA knowledge, and strong leadership. This position supports remote work within the US with travel to Cambridge, MA and occasional international travel.