Job Description

The Opportunity

We are seeking an R&D Operations Manager to lead operational planning and execution across our preclinical research and development organization. This role serves as a key business partner to scientific leadership, enabling efficient execution of toxicology, bioanalytical, translational, and research activities through strong operational oversight, vendor management, financial planning, and process optimization.

The R&D Operations Manager will be responsible for driving operational excellence across a growing preclinical organization, ensuring studies, vendors, budgets, contracts, and critical deliverables are managed proactively and efficiently. This position offers broad visibility across R&D and significant interaction with scientific leaders, external CROs, Finance, Procurement, Legal, and Quality.

Responsibilities

Operational Leadership

• Support operational planning and execution activities supporting preclinical, toxicology, bioanalytical, and translational research programs.
• Partner with scientific leadership to develop and maintain integrated study plans, timelines, milestones, and operational deliverables.
• Support identification of operational risks, develop and maintain program level risk tracker, and proactively work with scientific teams to develop mitigation strategies to support successful study execution.
• Establish, implement, and continuously improve operational processes, tools, templates, and governance frameworks that increase organizational efficiency and scalability.
• Support the Department Head with scheduling and executive assistant-based activities with approximate 15% time allocation.

Vendor and CRO Management

• Serve as the primary operational lead for CROs, laboratories, consultants, and other external vendors supporting preclinical programs.
• Manage vendor onboarding, contract initiation, statements of work, purchase orders, amendments, and vendor performance tracking.
• Partner closely with Procurement, Legal, Finance, and Quality to ensure timely execution of agreements and vendor-related activities.
• Monitor vendor deliverables, timelines, and budget performance, escalating issues as needed.

Study and Portfolio Operations

• Facilitate department-level and cross-functional meetings, lead meeting notes and tracking of decisions, action items, and deliverables with clear documentation and tracking to completion.
• Maintain operational oversight of study documentation, ensuring protocols, reports, contracts, and associated records are inspection-ready and appropriately archived.

Financial and Resource Management

• Manage operational budgets for preclinical and toxicology activities, including purchase order management, invoice reconciliation, accrual tracking, and spend forecasting in partnership with the department head.
• Partner with Finance to support annual budget planning and quarterly forecasting activities.
• Develop reporting and dashboards that provide visibility into program level and study level costs, vendor spend, and resource utilization.

Continuous Improvement

• • Develop metrics and key performance indicators to measure operational effectiveness across preclinical programs.
  • Identify opportunities to streamline workflows, reduce cycle times, and improve collaboration across internal and external stakeholders.
  • Champion a culture of operational excellence, accountability, and continuous improvement.

Required Qualifications

• Bachelor’s degree in Life Sciences, Business, Operations, or a related field.
• 6+ years of experience in biotechnology, pharmaceutical, CRO, or life sciences environments.
• 3+ years of experience supporting preclinical development, toxicology, translational research.
• Demonstrated experience managing vendors, CROs, contracts, budgets, and operational processes.
• Experience partnering cross-functionally with scientific, finance, procurement, legal, and quality organizations.
• Strong project management and organizational skills with the ability to manage multiple complex priorities simultaneously.
• Excellent written and verbal communication skills and the ability to influence stakeholders across all levels of the organization.
• Proficiency with Microsoft Office and common business systems; experience with NetSuite, LinkSquares, Smartsheet, or project management platforms is preferred.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You 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.) at your remote location.