[Hiring] Director, Clinical Business Operations @Amylyx Pharmaceuticals

Role Description

Amylyx is seeking an experienced Director, Clinical Business Operations, to join Amylyx’s Development Sciences organization. This newly created role will report to the Senior Director, Clinical Business Operations & Strategic Partnering, Clinical Operations. The Director will be responsible for building and advancing the clinical business operations capabilities that support efficient, scalable, and high-quality execution across Amylyx’s clinical development portfolio.

The Director, Clinical Business Operations will establish the infrastructure, processes, tools, and partnerships needed to enable these models effectively. This individual will lead the evolution of traditional clinical outsourcing activities into a broader Clinical Business Operations capability, with responsibility for vendor strategy and oversight, ensuring seamless execution of:

• Contracting and procurement processes
• Operational and financial planning
• Development of tools and standards that improve consistency and decision making across Clinical Operations

The Director will work closely with various teams to ensure operational infrastructure and external partnerships are in place for successful clinical program execution.

Responsibilities

• Drive the development and evolution of Clinical Business Operations, establishing scalable processes, tools, and capabilities.
• Develop and implement a strategic approach to clinical outsourcing and external resourcing.
• Partner with Clinical Operations leadership and cross-functional Study Management Teams to evaluate operational needs.
• Establish and maintain a comprehensive clinical vendor library.
• Lead or coordinate vendor identification, evaluation, selection, due diligence, and contracting activities.
• Support the development and negotiation standards of requests for proposals, scopes of work, budgets, and agreements.
• Establish consistent processes and governance for managing clinical vendors throughout the engagement lifecycle.
• Develop tools and frameworks for evaluating vendor performance, quality, cost, and service delivery.
• Build strong relationships with strategic CRO, FSP, and vendor partners.
• Develop and maintain meaningful operational metrics, dashboards, and reporting.
• Identify opportunities to streamline and standardize Clinical Operations business processes.
• Partner with Clinical Systems to identify opportunities to automate or digitize processes.
• Support development and maintenance of Clinical Business Operations procedures, templates, tools, and standards.
• Serve as a trusted business partner to Clinical Operations leaders and Study Teams.
• Foster a culture of collaboration, accountability, operational excellence, continuous improvement, and patient focus.

Qualifications

• Bachelor's degree in Life Sciences, Business, or a related field; advanced degree preferred.
• 10+ years of experience in clinical operations, outsourcing, vendor oversight, or business operations.
• Extensive experience supporting global clinical development programs.
• Expertise in outsourcing strategies and management of CROs, FSPs, CSPs, and specialty vendors.
• Proven experience with vendor selection, RFPs, proposal evaluation, and contracting.
• Strong knowledge of clinical trial budgeting, forecasting, and financial reporting.
• Experience developing scalable processes, tools, and governance frameworks.
• Working knowledge of clinical trial execution and the roles of Clinical Operations.
• Solid understanding of GCP, ICH guidelines, and applicable clinical trial regulations.
• Demonstrated ability to collaborate effectively with cross-functional stakeholders.
• Strong analytical skills with the ability to translate data into actionable recommendations.
• Excellent negotiation, vendor management, relationship-building, and communication skills.
• Strong organizational and project management capabilities.
• Proven track record of driving process improvements and implementing scalable solutions.
• Ability to balance strategic thinking with hands-on execution.
• Commitment to collaboration, accountability, continuous improvement, and cross-functional partnership.

Work Location and Conditions

• Remote work opportunities within the United States.
• Travel to corporate location in Cambridge, MA several times a year.
• Must have access to a work setting that meets all role requirements.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications.

• Estimated Pay Range: $200,000 — $239,000 USD