Director, Clinical Outsourcing Vendor Management

Amylyx is seeking an experienced Director, Clinical Outsourcing Vendor Management, 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 role will establish the infrastructure, processes, tools, and partnerships needed to enable internal resources, functional service providers (FSPs), hybrid models, and full-service outsourcing, and will lead the evolution of traditional clinical outsourcing activities into a broader Clinical Business Operations capability.

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; Establish and maintain a comprehensive clinical vendor library, providing visibility into vendor capabilities, optionality, contractual terms, historical performance, pricing, and utilization; 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 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; Build strong relationships with strategic CRO, FSP, and vendor partners and support appropriate governance and escalation mechanisms; Develop and maintain operational metrics, dashboards, and reporting providing 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 flexibility across programs, study designs, geographies, and operating models; Partner with Clinical Systems to identify opportunities to automate or digitize Clinical Business Operations processes; 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; Foster a culture of collaboration, accountability, operational excellence, continuous improvement, and patient focus

Requirements

Bachelor's degree in Life Sciences, Business, or a related field; 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

Nice to have

Advanced degree