Associate Director, Clinical Outsourcing Vendor Management

The role

The Associate Director will build and advance clinical business operations capabilities to support the clinical development portfolio. This role involves establishing infrastructure, processes, and partnerships for vendor strategy and oversight.

What you will do

• Drive the development and evolution of Clinical Business Operations.
• Develop and implement a strategic approach to clinical outsourcing and external resourcing.
• Partner with Clinical Operations leadership to determine resourcing and outsourcing strategies.
• Establish and maintain a comprehensive clinical vendor library.
• Lead vendor identification, evaluation, selection, due diligence, and contracting.
• Support development and negotiation of RFPs, SOWs, budgets, and agreements.
• Establish processes and governance for managing clinical vendors throughout the engagement lifecycle.
• Develop tools and frameworks for evaluating vendor performance, quality, and cost.
• Build relationships with strategic CRO, FSP, and vendor partners.
• Develop and maintain operational metrics, dashboards, and reporting.

Required qualifications

• Bachelor's degree in Life Sciences, Business, or a related field
• 8+ 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
• Expertise in outsourcing strategies and management of CROs, FSPs, CSPs, and specialty vendors
• 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
• Ability to collaborate effectively with Finance, Procurement, Legal, Quality, Clinical Operations, and other cross-functional stakeholders
• Strong analytical skills
• Excellent negotiation, vendor management, relationship-building, communication, and influencing skills

Nice to have

• advanced degree

Benefits

• competitive base pay
• annual performance-based bonuses
• equity awards
• comprehensive benefits package

Before you apply

• unable to hire employees who reside and/or work in certain states
• not considering applicants from Alaska and Hawaii
• must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.)

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs through rigorous science and an experienced team.