Natera

Compensation

Full Description

Job Description: • Lead complex IVD/CDx programs through development, design transfer, validation, and PMA submission • Build and maintain integrated program plans 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 cross-functional decisions • Establish program governance, ownership, escalation paths, and accountability • 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 execution with FDA interactions, requirements, and PMA evidence needs • Coordinate assay changes, comparability or bridging studies, and transition to final CDx configuration • Lead major development-gate reviews and confirm readiness, risks, and decisions • Track submission-critical evidence and documentation and resolve gaps affecting PMA quality or timing • Present strategy, progress, risks, trade-offs, and recommendations to the ELT and senior governance forums • Translate scientific, operational, and regulatory issues into data-backed options and decisions • Build leadership alignment, hold teams accountable, and escalate material issues • Provide internal program status and decision support to colleagues managing external pharmaceutical partnerships Requirements: • 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 • 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 • Ability to connect technical decisions, resource needs, regulatory evidence, and timelines to overall program strategy • Preferred: experience leading a CDx or IVD program through PMA submission or a major PMA milestone • Preferred: experience with next generation sequencing, genomic diagnostics, or biomarker-defined patient populations • Preferred: experience coordinating analytical and clinical validation strategies and managing changes between clinical trial and final commercial assay configurations • Preferred: familiarity with pharmaceutical development timelines and dependencies between therapeutic programs and companion diagnostics • Preferred: advanced degree or program management certification Benefits: • Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program • Equal opportunity and inclusive workplace