Associate Director, Strategic Program Management

Natera

. Lead complex IVD/CDx programs through development, design transfer, validation, and PMA submission .

Posted 11/2/2026full-timeRemote • United StatesSenior💰 $150,300 - $195,150 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading complex IVD and CDx programs through all phases of development, including design transfer, validation, and PMA submission. Proficient in building integrated program plans and collaborating with cross-functional teams to ensure alignment with regulatory requirements and strategic objectives.

Highest-signal resume keywords

IVD Development Program LeadershipPMA Submission PreparationCross-Functional Stakeholder ManagementRegulatory Affairs CollaborationIntegrated Program Planning

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Program ManagementDesign ControlsValidation PlanningAnalytical ValidationClinical ValidationAssay DevelopmentNext Generation SequencingBiomarker-Defined Patient PopulationsRegulatory ComplianceDocumentation Tracking

Soft Skills

Leadership AlignmentRisk ManagementDecision-MakingCommunicationAccountability

Certifications & Qualifications

Program Management Certification

Industry Keywords

Molecular DiagnosticsIn Vitro DiagnosticsMedical DevicesBiotechnologyFDA InteractionsClinical Trial ManagementPharmaceutical DevelopmentCompanion Diagnostics

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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