Associate Director, Strategic Program Management

Associate Director, Strategic Program Management, CDx/IVD Position Overview Natera is seeking an Associate Director of Strategic Program Management to lead IVD and companion diagnostic (CDx) programs from development planning through PMA submission. This leader will shape the development strategy with functional experts and own the integrated execution plan across assay development, software and bioinformatics, analytical and clinical validation, laboratory operations, Quality, and Regulatory Affairs. The Associate Director will bring clarity to complex programs, connect decisions across workstreams, and drive teams toward critical development and submission milestones. This is a highly visible role requiring the ability to lead without direct authority, resolve competing priorities, and present clear recommendations to the Executive Leadership Team (ELT). The role focuses on internal CDx development and execution; dedicated partnership leaders own external pharmaceutical partner management. Primary Responsibilities Lead IVD/CDx program execution Lead complex IVD/CDx programs through development, design transfer, validation, and PMA submission. Build and maintain an integrated program plan covering deliverables, resources, dependencies, decision points, and regulatory milestones. Partner with functional leaders to define objectives, development priorities, success criteria, and executable plans. Anticipate risks, identify gaps and trade-offs, and drive timely decisions across functions. Establish clear program governance, ownership, escalation paths, and accountability for commitments. Drive development and submission readiness Integrate assay development, design controls, software and bioinformatics, analytical validation, clinical validation, laboratory implementation, and submission activities. Partner with Regulatory Affairs and Quality to align program execution with FDA interactions, applicable requirements, and PMA evidence needs. Coordinate plans for assay changes, comparability or bridging studies, and transition to the final CDx configuration, as applicable. Lead reviews at major development gates to confirm deliverables, readiness criteria, open risks, and decisions. Track submission-critical evidence and documentation, and drive resolution of gaps that could affect PMA quality or timing. Provide executive leadership and communication Present program strategy, progress, risks, trade-offs, and recommendations to the ELT and other senior...

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