Director, Clinical Business Operations

Amylyx Pharmaceuticals•Cambridge, MA

10h•$200,000 - $239,000•Remote

About The Position

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. As Amylyx evolves its Clinical Operations model and expands its internal capabilities, we are taking a more strategic and flexible approach to how clinical development work is resourced and delivered. Depending on the needs of an individual program or study, Amylyx may utilize internal resources, functional service providers (FSPs), hybrid models, or full-service outsourcing. 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, and development of tools and standards that improve consistency and decision making across Clinical Operations. The Director will work closely with the Clinical Operations Leadership, Development Sciences organization, Clinical Program and Study Teams, Global Site Services, Quality, Compliance, Finance, Procurement, Legal, and other cross-functional partners to ensure teams have the operational infrastructure and external partnerships required to successfully execute clinical programs. This is an opportunity for a highly collaborative and solutions-oriented leader to drive the modernization of clinical outsourcing operations to support Amylyx’ s clinical development portfolio scale-up and help to define how Amylyx plans, resources, contracts, and manages its clinical development activities as the organization grows.

Requirements

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 within biotech, pharmaceutical, or clinical research settings.
Extensive experience supporting global clinical development programs, including clinical business operations, outsourcing, and vendor management.
Expertise in outsourcing strategies and management of CROs, FSPs, CSPs, and specialty vendors, including governance, performance oversight, and contract management.
Proven experience with vendor selection, RFPs, proposal evaluation, contracting, scope development, change orders, and vendor governance.
Strong knowledge of clinical trial budgeting, forecasting, accruals, financial reporting, and cost control.
Experience developing scalable processes, tools, and governance frameworks within Clinical Operations.
Working knowledge of clinical trial execution and the roles of Clinical Operations, study teams, CROs, sites, and external partners.
Solid understanding of GCP, ICH guidelines, and applicable clinical trial regulations.
Demonstrated ability to collaborate effectively with Finance, Procurement, Legal, Quality, Clinical Operations, and other cross-functional stakeholders.
Strong analytical skills with the ability to translate operational and financial data into actionable recommendations.
Excellent negotiation, vendor management, relationship-building, communication, and influencing skills.
Strong organizational and project management capabilities, with the ability to manage multiple priorities in a fast-paced environment.
Proven track record of driving process improvements and implementing practical, scalable solutions.
Ability to balance strategic thinking with hands-on execution in a dynamic biotechnology environment.
Commitment to collaboration, accountability, continuous improvement, and cross-functional partnership.

Responsibilities

Drive the development and evolution of Clinical Business Operations, establishing scalable processes, tools, and capabilities that support Amylyx’s clinical development portfolio.
Develop and implement a strategic approach to clinical outsourcing and external resourcing, supporting the appropriate use of full-service CROs, FSPs, specialized vendors, consultants, and other external partners.
Partner with Clinical Operations leadership and the cross-functional Study Management Teams to evaluate operational needs and determine fit-for-purpose resourcing and outsourcing strategies based on program and study requirements.
Establish and maintain a comprehensive clinical vendor library, providing greater visibility into vendor capabilities, optionality, contractual terms, historical performance, pricing, and utilization across the portfolio.
Lead or coordinate vendor identification, evaluation, selection, due diligence, and contracting activities for Clinical Operations in partnership with Procurement, Legal, Finance, and functional stakeholders.
Support, in partnership with Legal and Procurement business partners, the development and negotiation standards of requests for proposals, scopes of work, budgets, change orders, master service agreements, and other agreements supporting clinical activities.
Establish consistent processes and governance for managing clinical vendors throughout the engagement lifecycle, from selection and contracting through performance management and closeout.
Develop tools and frameworks for evaluating vendor performance, quality, cost, service delivery, and operational effectiveness, enabling informed decisions about future partnerships.
Build strong relationships with strategic CRO, FSP, and vendor partners and support appropriate governance and escalation mechanisms.
Develop and maintain meaningful operational metrics, dashboards, and reporting that provide leadership with visibility into outsourcing activity, vendor performance, contracting timelines, spend, and other key business operations indicators.
Identify opportunities to streamline and standardize Clinical Operations business processes while preserving the flexibility needed to support different programs, study designs, geographies, and operating models.
Partner with Clinical Systems to identify opportunities to automate or digitize Clinical Business Operations processes and improve access to operational and financial information.
Support development and maintenance of Clinical Business Operations procedures, templates, tools, and standards related to outsourcing, vendor management, budgeting, contracting, and business operations.
Serve as a trusted business partner to Clinical Operations leaders and Study Teams, bringing strong operational judgment, financial discipline, and a solutions-oriented approach to complex business challenges.
Foster a culture of collaboration, accountability, operational excellence, continuous improvement, and patient focus.