Senior Manager, Study Management & Outsourcing

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is expanding its impact across Canada, with commercial operations in Toronto and a strategic manufacturing partnership in Laval. In Toronto, we bring our mRNA medicines to patients nationwide. In Laval, our mRNA vaccine facility will strengthen pandemic preparedness and rapid access to vaccines.

Join us to help advance biotechnology and support Canada’s leadership in global health. This is an opportunity to lead sponsor‑side oversight of critical nonclinical studies that directly influence the advancement of Moderna's innovative mRNA medicines. As the Canada‑based study owner, you will provide scientific, technical, and operational leadership across outsourced GLP and non‑GLP studies, ensuring every stage—from protocol development through final report—delivers high‑quality data that enables strategic decision‑making and supports global regulatory submissions.

• Lead sponsor‑side oversight of GLP and non‑GLP nonclinical studies from protocol development through final report, providing scientific and technical leadership across study rationale, protocol design, endpoint selection, data review, interpretation, and reporting to support critical development and regulatory decisions.
• Serve as the study owner with accountability for study quality, timelines, budgets, deliverables, operational execution, and overall study outcomes.
• Ensure all studies are conducted in compliance with GLP (where applicable), global regulatory expectations, and inspection‑ready standards throughout the study lifecycle.
• Provide Canada‑based leadership and scientific guidance to Study Monitors, promoting consistency, quality, and operational excellence.
• Act as the primary sponsor contact for Canada‑based CROs, building strong collaborative partnerships while ensuring clear communication, documentation of decisions, and appropriate oversight of work performed on Moderna's behalf.
• Develop, negotiate, and review Statements of Work (SOWs), ensuring scope, timelines, budgets, deliverables, change controls, and study objectives remain aligned with program priorities.
• Monitor CRO performance, proactively identify operational or scientific risks, drive issue resolution, and escalate challenges appropriately to maintain study progress.
• Lead protocol development, protocol amendments, deviation management, scientific review, and approval of final study reports.
• Oversee study conduct through continuous review of emerging data, protocol deviations, scientific findings, unexpected observations, inconclusive results, and recommendations for additional analyses or study modifications when appropriate.
• Conduct Canada‑based site visits and observe CRO activities as required to ensure effective sponsor oversight.
• Coordinate cross‑functional scientific review of protocols, data packages, interim analyses, and final reports.
• Drive alignment across Toxicology, Drug Metabolism & Pharmacokinetics (DMPK), Pathology, Bioanalytical, Program Management, Therapeutics, Platform Research, and other key stakeholders to ensure integrated study planning, execution, interpretation, and decision‑making.
• Clearly communicate study progress, scientific findings, operational risks, mitigation strategies, and key outcomes to internal stakeholders to support informed business decisions.
• Develop and manage detailed study timelines, budgets, resource plans, and execution strategies focused on efficiency, quality, and impact.
• Maintain complete audit‑ and inspection‑ready documentation, including study records, decision logs, meeting minutes, scientific rationale, reviewed results, conclusions, and recommended next steps.
• Ensure data integrity and robust sponsor oversight throughout every phase of outsourced nonclinical studies.
• Independently manage multiple complex studies, CRO partnerships, vendors, and cross‑functional work streams within a fast‑paced matrix organization while exercising sound scientific judgment and operational accountability.
• Apply strong knowledge…