Senior Manager, Study Management – Outsourcing

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Moderna

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2010

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Moderna is a biotechnology company focused on exploring the potential of messenger RNA (mRNA) science to develop a new generation of medicines. With 45 products in the pipeline and 36 ongoing clinical trials, Moderna aims to revolutionize treatment possibilities by enabling the immune system to combat diseases more effectively. Their platform allows for the rapid design, research, and testing of multiple mRNAs, facilitating faster delivery of medicines to patients.

📋 Description

• 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 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 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 discipline with 7+ years of relevant experience in nonclinical drug development; OR Master’s degree with 5+ years of relevant experience; OR PhD with 3+ years of relevant experience in the pharmaceutical or biotechnology industry. • Demonstrated experience serving as a sponsor-side Study Monitor or Study Manager supporting nonclinical GLP and/or non-GLP nonclinical 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 assess whether CRO study plans, methods, endpoints, and deliverables are fit-for-purpose for the scientific questions being investigated. • Demonstrated operational understanding of the end-to-end conduct of nonclinical studies, for example: protocol development, test article formulation, handling and testing, in-life procedures and endpoint collection, pharmacokinetic/bioanalytical integration, pathology evaluation, data quality review, and report finalization. • Demonstrated ability to manage multiple complex studies or workstreams simultaneously within a fast-paced, matrixed development environment. • Strong analytical, organizational, and communication skills with attention to detail and a commitment to data integrity and compliance. • Ability to influence cross-functional stakeholders and external partners without direct authority. • Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of 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 make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

🏖️ Benefits

• Competitive healthcare coverage, plus voluntary benefit programs tailored to your individual needs. • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support services. • Family-building benefits, including support for 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 help you plan for your future. • Location-specific perks and extras.