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 governance forums.
• Translate complex scientific, operational, and regulatory issues into concise, data-backed options and decisions.
• Build alignment among leaders with different priorities and hold teams accountable for agreed actions and milestones.
• Escalate material issues early, with a clear assessment of their impact and a recommended path forward.
• Provide the internal program status and decision support needed by colleagues who lead external pharmaceutical partner relationships.

Qualifications

Required

• Bachelor’s degree in life sciences, engineering, or a related field, or equivalent relevant experience.
• 10+ years of progressive program or project management experience in molecular diagnostics, in vitro diagnostics, medical devices, biotechnology, or a related regulated field.
• Direct experience leading CDx or IVD development programs involving design controls, validation planning, and FDA submission preparation.
• Experience building and driving integrated plans across technical, clinical, regulatory, quality, software, and operations functions.
• Demonstrated ability to lead senior cross-functional stakeholders, resolve competing priorities, and deliver results without direct reporting authority.
• Experience presenting complex programs, risks, and recommendations to executive leadership.
• Strong ability to connect technical decisions, resource needs, regulatory evidence, and timelines to the overall program strategy.

Preferred

• Experience leading a CDx or IVD program through PMA submission or a major PMA milestone.
• Experience with next generation sequencing, genomic diagnostics, or biomarker-defined patient populations.
• Experience coordinating analytical and clinical validation strategies and managing changes between clinical trial and final commercial assay configurations.
• Familiarity with pharmaceutical development timelines and the dependencies between a therapeutic program and its companion diagnostic.
• Advanced degree or program management certification.

Leadership Expectations

The successful candidate will lead the program beyond milestone tracking. They will understand the science and regulatory strategy well enough to ask informed questions, recognize when a decision in one workstream creates risk elsewhere, and bring the right leaders together to resolve it. They will foster trust and open discussion, make ownership clear, and give executives an accurate view of progress and the decisions needed to deliver the program.