Medical Director - Operations, Governance, & Digital

About the role

Job Description Summary The Operations, Governance, & Digital Medical Director for the US and Canada, leads the operational backbone of the US/CAN Medical Affairs, ensuring compliant, efficient, and high‑quality execution of medical strategies across the PDx portfolio. The role enables delivery of Medical Information, medical governance, Clinical application expertise, training, publications and congress operations, and evidence execution support with a strong focus on operational excellence, cross‑functional coordination, and audit readiness. This role is critical to translating scientific strategy into compliant operational delivery, supporting US/CAN business objectives and global GMA standards. This role manages a team and partners closely with Medical Affairs, Patient Safety, Regulatory, Quality, Compliance, Clinical Applications team and Commercial colleagues to support safe, effective, and ethical medical engagement. Job Description Core responsibilities: The key responsibilities include (but are not limited to): Strategy & Planning Lead US/CAN Medical Operations strategy aligned with GMA global frameworks, PDx priorities, and US/CAN Medical Affairs strategic plans. Drive operational planning cycles (annual plans, OKRs, operating rhythms) including medical activity tracking, dashboards, KPIs, and compliance documentation. Translate scientific and medical priorities into executable operational processes, systems, and workflows. Partner with US/CAN Medical leadership to ensure operational resourcing, budget planning, forecasting, vendor oversight, and contracting compliance. Contribute to operational design of US/CAN medical launch readiness, evidence initiatives, field excellence activities, and cross‑functional accountability planning. Lead Clinical Medical Application team, aligning the strategy for technologists networking, training and education. External Stakeholder Engagement (Operational Leadership) Enable compliant and efficient external engagement by ensuring operational readiness of medical systems, tools, and processes (CRM/insights, congress management, publication tracking, SOP‑guided processes). Support field medical operations excellence: insights capture frameworks, strategic account planning enablement, and metrics dashboards. Lead Field Clinical medical application team: insights capture frameworks, strategic account planning enablement, sites training, education and metrics dashboards Coordinate US/CAN presence at scientific congresses, ensuring alignment with global congress governance and impact‑based planning. Leads the scientific communication team ensuring accurate scientific exchange with external stakeholders overseeing APR (Promotional materials review ) process and teams. Scientific Communications & Publications Oversee operational processes supporting publications and congress planning in the US/CAN, aligned with global Strategy & Operations frameworks. Ensure US/CAN operational compliance for publication planning, authorship documentation, evidence communication workflows, and post‑congress reporting. Maintain dashboards/reporting for publication progress, congress activities, and US/CAN medical communications workflows. Evidence Generation (Operational Execution & Governance) Leads US/CAN operational governance of medical evidence activities (IST/ISS, MA‑sponsored studies, post‑marketing commitments) in alignment with global frameworks. Ensure accurate visibility and tracking of all evidence activities through standardized tools (registries, trackers, dashboards). Manage operational interfaces with Clinical Operations, Regulatory, Safety, and Compliance to support study startup, contracting, training, and oversight. HCP Foundational Services Lead US/CAN Medical Information operations, ensuring high‑quality inquiry management, process compliance, accurate documentation, and timely response development. Oversee maintenance and governance of US/CAN medical content, including standard response letters, FAQs, and knowledge repositories. Support training of Medical Affairs colleagues on MI processes, SOPs, compliance expectations, and medical governance systems. Partner with GMA Strategy & Operations to implement global SOP changes, policy updates, and system enhancements within the US/CAN region. Medical Governance Maintain robust oversight of US/CAN medical SOPs, policies, training matrices, and audit preparation activities. Ensure ongoing audit and inspection readiness across all US/CAN Medical Operations domains. Support internal reviews, CAPA development, and remediation activities in partnership with Compliance, Quality, and Patient Safety. Oversee processes related to external material review, documentation governance, and cross‑functional medical compliance. Training, People Development & Talent Management Lead, coach, and develop the USCAN Medical Operations team; support role clarity, capabilities, and ongoing upskilling. Establish talent development pathways

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