Director, Clinical Operations

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Director, Clinical Operations is a senior member of the Amylyx Global Clinical Operations team responsible for the operational strategy, planning, execution, and oversight of assigned global clinical studies. Therapeutic areas may include:
Post Bariatric Hypoglycemia or other associated conditions, Amytrophic Lateral Sclerosis (ALS), Wolfram Syndrome and/or other diseases under study at Amylyx Pharmaceuticals.

This individual will provide end to end operational leadership for clinical trials, working with a high degree of independence in a small, fast-paced company environment. The Director will translate program and study strategy into executable operational plans and ensure delivery against timelines, budget, quality and compliance expectations.

The ideal candidate is an experienced clinical operations leader with demonstrated success managing complex global clinical trials, CROs, functional service providers and specialty vendors. This individual is proactive, solutions oriented, comfortable making risk-based decisions, and able to identify emerging issues before they impact study execution.

The Director will work closely with Clinical Operations leadership, Clinical Development, Regulatory, Data Management, Biostatistics, Pharmacovigilance, Clinical Compliance, Quality, Clinical Outsourcing, Finance, Legal and other internal functions while providing strong oversight and direction to external partners.

This individual should be a proactive problem-solver with proficient verbal and written communication skills, comfortable leading study teams working with ambitious timelines. The ideal candidate will also have previous experience managing clinical operations team members, and helping to shape their growth and development.

• Provide end-to-end operational leadership and accountability for assigned global clinical trials for the full study lifecycle with close attention to effective planning and execution, risk management, data integrity, quality and compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other regulations and patient safety standards.
• Oversee development and maintenance of integrated study operational plans, including timelines, enrollment assumptions, resource requirements, key dependencies, risks and contingency plans.
• Drive execution against study milestones, proactively identifying risks, issues, trends, and interdependencies and ensuring appropriate mitigation, escalation and resolution.
• Ensures appropriate operational procedures are implemented or adhered to, to assure high quality trial data and operational excellence of assigned studies.
• Develops, analyses, and reports on metrics for clinical programs.
• In conjunction with Clinical Leadership, ensures study deliverables are achieved on time and within budget.
• Contributes to the development of study documentation including protocols, study manuals, ICFs, CRFs, Clinical Study…