Senior Manager, Study Management & Outsourcing (Canada)

About the Role

As Senior Manager, Study Management & Outsourcing (Canada), you will lead sponsor-side oversight of critical nonclinical studies (GLP and non-GLP) and act as the Canada-based study owner, providing scientific, technical, and operational leadership from protocol development through final report. You will partner with multidisciplinary teams and external CROs to ensure data quality, regulatory readiness, and timely decision-making, leveraging advanced digital technologies and AI-enabled tools to optimize planning, documentation, data review, and execution. What You'll Do

• 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, 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 workstreams within a fast-paced matrix organization while exercising sound scientific judgment and operational accountability.

• Apply strong knowledge of GLP regulations and global nonclinical regulatory guidance, including ICH, FDA, and EMA expectations.

• Assess CRO study plans, methodologies, endpoints, and deliverables to ensure they are scientifically appropriate and fit-for-purpose.

• Leverage your understanding of end-to-end nonclinical drug development, including protocol development, test article formulation, handling and testing, in-life procedures, endpoint collection, pharmacokinetic and bioanalytical integration, pathology evaluation, data quality review, and report finalization.

• Influence cross-functional partners and external stakeholders without direct authority, fostering collaboration and delivering results across multiple concurrent programs.

• Thrive in a dynamic environment by adapting quickly to new scientific findings, evolving priorities, and changing development strategies.

• Mentor and support colleagues across the Nonclinical Drug Development Science. What We're Looking For

• Proven experience leading sponsor-side oversight of GLP and non-GLP nonclinical studies and managing CRO partnerships in a highly matrixed environment.

• Strong knowledge of GLP regulations and global nonclinical regulatory guidance (ICH, FDA, EMA).

• Ability to lead cross-functional teams (Toxicology, DMPK, Pathology, Bioanalytical, Program Management, Therapeutics, Platform Research) and communicate complex data effectively.

• Excellent communication, documentation, and stakeholder-management skills; able to serve as primary sponsor contact and drive alignment without direct authority.

• Strong project management capabilities: budgeting, timelines, resource planning, risk mitigation, and issue resolution.

• Canada-based location or eligibility to work in Canada, with the ability to collaborate across global teams. Nice to Have

• Experience leveraging advanced digital technologies and Generative AI-enabled tools to enhance study planning, documentation, data review, and operational excellence.