Associate Director, Strategic Program Management

Natera • US Remote, SC

6d • $150,300 - $195,150 • Remote

About The Position

Natera is seeking an Associate Director of Strategic Program Management to lead internal in vitro diagnostic (IVD) and companion diagnostic (CDx) programs from development planning through PMA submission. The role shapes development strategy with functional experts and owns integrated execution across assay development, software and bioinformatics, analytical and clinical validation, laboratory operations, Quality, and Regulatory Affairs.

This highly visible position brings clarity to complex programs, connects decisions across workstreams, and drives teams toward critical development and submission milestones. The Associate Director leads without direct authority, resolves competing priorities, and presents clear recommendations to the Executive Leadership Team and other senior governance forums. Dedicated partnership leaders manage external pharmaceutical partner relationships; this role provides them with internal program status and decision support.

The successful candidate will understand the science and regulatory strategy sufficiently to recognize cross-workstream risks, convene the right leaders, establish clear ownership, foster open discussion, and give executives an accurate view of progress and decisions needed.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field, or equivalent relevant experience.
• 10 or more 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.
• Ability to connect technical decisions, resource needs, regulatory evidence, and timelines to overall program strategy.

Nice To Haves

• 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 dependencies between a therapeutic program and its companion diagnostic.
• Advanced degree or program management certification.

Responsibilities

• 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 decisions across functions.
• Establish program governance, ownership, escalation paths, and accountability for commitments.
• 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, 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 major development-gate reviews 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.
• 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, assess their impact, and recommend a path forward.
• Provide internal program status and decision support to colleagues leading external pharmaceutical partner relationships.

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.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director