Remote Associate Director CDx Program Strategy

Natera; United States; Remote; USD 150.000 - 195.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Free testing for employees and depend­

Pregnancy and baby bonding leave

401k benefits

Commuter benefits

Employee referral program

Zusammenfassung

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.

Qualifikationen

• Bachelor’s degree in life sciences, engineering, or 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.

Aufgaben

• 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.

Kenntnisse

Leadership across functions

Executive stakeholder management

Program management

Regulatory/compliance awareness

Strategic planning

Communication to ELT

Ausbildung

Bachelor’s degree in life sciences, engineering, or related field

Jobbeschreibung

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.