Senior Manager, Study Management – Outsourcing

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee sponsor-side management of GLP and non-GLP nonclinical studies from protocol development to final report, providing scientific and technical guidance on study rationale, protocol design, endpoint selection, data review, interpretation, and reporting to facilitate important development and regulatory decisions.

• Act as the study owner, responsible for study quality, timelines, budgets, deliverables, operational execution, and overall outcomes.

• Ensure all studies comply with GLP (where applicable), global regulatory standards, and maintain inspection-ready documentation throughout the study lifecycle.

• Provide leadership and scientific expertise to Study Monitors in Canada, ensuring consistency, quality, and operational excellence.

• Serve as the main sponsor contact for Canada-based CROs, fostering strong collaborative relationships while ensuring effective communication, decision documentation, and proper oversight of work conducted on Moderna's behalf.

• Develop, negotiate, and review Statements of Work (SOWs), ensuring alignment of scope, timelines, budgets, deliverables, change controls, and study objectives with program priorities.

• Monitor CRO performance, proactively identify operational or scientific risks, drive issue resolution, and escalate challenges as necessary to maintain study progress.

• Lead protocol development, amendments, deviation management, scientific review, and the approval of final study reports.

• Oversee study execution through ongoing review of emerging data, protocol deviations, scientific findings, unexpected observations, inconclusive results, and recommendations for further analysis or study modifications when appropriate.

• Conduct site visits in Canada and observe CRO activities as needed to ensure effective sponsor oversight.

• Coordinate cross-functional scientific reviews of protocols, data packages, interim analyses, and final reports.

• Drive alignment among 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.

• Communicate study progress, scientific findings, operational risks, mitigation strategies, and key outcomes to internal stakeholders to support informed business decisions.

• Develop and manage comprehensive 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 all phases 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 extensive knowledge of GLP regulations and global nonclinical regulatory guidance, including ICH, FDA, and EMA expectations.

• Evaluate CRO study plans, methodologies, endpoints, and deliverables to ensure they are scientifically valid and appropriate for the intended objectives.

• Utilize your understanding of the complete nonclinical drug development process, 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 achieving results across multiple concurrent programs.

• Excel in a dynamic environment by adapting swiftly to new scientific findings, shifting priorities, and changing development strategies.

• Mentor and support colleagues across the Nonclinical Drug Development Science organization, contributing to a collaborative culture focused on innovation, continuous improvement, operational excellence, and scientific rigor.

⛳️ Requirements

• Bachelor’s degree in toxicology, pharmacology, biological sciences, or a related field with 7+ years of pertinent experience in nonclinical drug development; OR Master’s degree with 5+ years of relevant experience; OR PhD with 3+ years of applicable experience in the pharmaceutical or biotechnology sector.

• Proven experience serving as a sponsor-side Study Monitor or Study Manager for nonclinical GLP and/or non-GLP studies.

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

• Experience managing CRO partnerships, including protocol development, study oversight, issue resolution, and report review, with the ability to evaluate whether CRO study plans, methods, endpoints, and deliverables are appropriate for the scientific queries being addressed.

• Demonstrated operational understanding of the comprehensive conduct of nonclinical studies, including protocol development, test article formulation, handling and testing, in-life procedures, endpoint collection, pharmacokinetic/bioanalytical integration, pathology evaluation, data quality review, and report finalization.

• Proven ability to manage multiple complex studies or workstreams concurrently within a fast-paced, matrixed development environment.

• Strong analytical, organizational, and communication skills with meticulous attention to detail and a commitment to data integrity and compliance.

• Capability to influence cross-functional stakeholders and external partners without direct authority.

• Demonstrated ability to thrive in a fast-paced and dynamic work environment, with the adaptability to swiftly adjust in response to new data and/or strategic directions.

• Proven ability to independently manage studies/projects and partnerships/stakeholders in a remote or hybrid environment, demonstrating strong professional judgment, communication skills, and operational accountability.

• A desire to contribute positively as part of a high-growth, transformational company that embodies boldness, relentlessness, curiosity, and collaboration.

🏝️ Benefits

• Competitive healthcare coverage, along with voluntary benefit programs tailored to your individual needs.

• A holistic approach to well-being, providing access to fitness, mindfulness, and mental health support services.

• Family-building benefits, including assistance with fertility, adoption, and surrogacy.

• Generous time-off offerings, including vacation, public holidays, volunteer days, sabbaticals, global recharge days, and a discretionary year-end shutdown.

• Savings and investment solutions to assist you in planning for your future.

• Location-specific perks and additional benefits.