Manager, R&D Operations
Amylyx Pharmaceuticals · Cambridge, MA · 2 wk ago
HybridInformation Technology$123k–$138k/yrFull-time
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.
- Identify 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.
- 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.
Requirements
- 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.