Associate Director, Operations Oversight Lead Medical Affairs Research Global Operations (MARGO)

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MARGO Background: The MARGO function is part of the wider Medical Affairs Research (MAR) department within the Development organization and operationalises Non Interventional Studies scientifically led from MAR. MAR conducts observational research and generates analysis results to inform decisions throughout the product lifecycle across research, development, post-approval, and commercialization. Observational research is conducted on data collected from individuals assessed for biomedical, health and other outcomes, and includes observational studies and observational analyses. Source data for observational studies may be based on primary data collection, secondary data use, or both. The study results, generated using a rigorous process, provide insights and evidence for internal (e.g., program, safety) and external (e.g., regulators, healthcare providers) stakeholders.

Summary: This role provides end-to-end operational oversight of observational studies within the MAR portfolio across all therapeutic areas (TA). This position supports the MAR team in high-quality, compliant and timely study execution of the study portfolio through effective vendor oversight, risk management and issue resolution. This role reports to the Director, MAARGO and is the primary point of contact for study operations for vendors and service providers. While not responsible for day-to-day execution, the role is responsible for collaborating with MAR scientific leads, Quality, Clinical Operations, Regulatory Affairs, Medical Affairs and other stakeholders to ensure vendors and service providers meet agreed-upon timelines and are compliant with process requirements and relevant regulatory guidelines. Key Responsibilities: • Responsible for working with the MARGO Leadership Team to track, prioritize and manage the execution of observational studies across all TA portfolios • Collaborate with MARGO Leadership Team on strategic sourcing options to optimize the execution of the TA portfolio • Responsible for vendor performance management, issue management and escalation of risks impacting the portfolio • Responsible for the vendor oversight plans, and performance and quality checks of study deliverables per the vendor oversight process • Partner with vendor outsourcing to support initiation and execution of study vendor and service provider agreements • Collaborate with MAR scientific leads to ensure alignment of study objectives and timelines across all stakeholders and vendors • Own end-to-end oversight of study deliverables, ensuring timely, high-quality completion aligned to TA priorities, with proactive risk identification and mitigation • Track study milestones, timelines, deliverables and financials; proactively identify and mitigate risks • Collaborate with MAR