Remote opportunity at
NateraAssociate Director, Strategic Program Management
Natera is seeking an Associate Director of Strategic Program Management for its companion diagnostic and in vitro diagnostic programs. The company operates globally as a leader…
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About This Role
Natera is seeking an Associate Director of Strategic Program Management for its companion diagnostic and in vitro diagnostic programs. The company operates globally as a leader in cell-free DNA testing across oncology, women's health, and organ health. This role centers on leading complex diagnostic initiatives from initial development through premarket approval submission. The incoming professional will establish integrated execution schedules, coordinate across functional areas like software, assay development, regulatory affairs,…
Job Description
Natera is seeking an Associate Director of Strategic Program Management for its companion diagnostic and in vitro diagnostic programs. The company operates globally as a leader in cell-free DNA testing across oncology, women's health, and organ health.
This role centers on leading complex diagnostic initiatives from initial development through premarket approval submission. The incoming professional will establish integrated execution schedules, coordinate across functional areas like software, assay development, regulatory affairs, and quality, and guide the team through major decision gates. The position requires presenting strategic updates and risk analyses directly to executive leadership while collaborating with internal colleagues who manage external pharmaceutical partnerships.
The position is remote within the USA, with a salary range of $150,300 to $195,150 USD, determined by factors such as experience, skills, and specific geographic location.
Responsibilities
- Manage comprehensive IVD and CDx programs from design and validation through PMA submission
- Develop and maintain unified program schedules tracking resources, deliverables, dependencies, and regulatory milestones
- Collaborate with functional department heads to establish goals, priorities, and actionable execution plans
- Identify potential risks, evaluate operational trade-offs, and facilitate prompt problem-solving across departments
- Define clear program governance frameworks, escalation pathways, and accountability standards
- Coordinate activities spanning assay design, software, bioinformatics, analytical and clinical validation, and laboratory implementation
- Partner with quality and regulatory teams to align execution with FDA guidelines and PMA requirements
- Lead formal gate reviews to assess readiness criteria, open risks, and milestone achievements
- Deliver strategic presentations, status updates, and data-backed recommendations to executive leadership and senior governance committees
- Supply internal status reports and decision support for teams managing external pharmaceutical alliances
Requirements
- 10 or more years of progressive project or program management experience in regulated fields such as molecular diagnostics, medical devices, biotechnology, or in vitro diagnostics
- Direct background leading CDx or IVD development projects that utilized design controls, validation planning, and FDA submission preparations
- Demonstrated ability to build and execute synchronized plans across operations, clinical, regulatory, quality, software, and technical teams
- Proven capacity to lead senior cross-functional stakeholders and achieve outcomes without direct management authority
- Experience briefing executive leadership on complex program structures, risks, and recommendations
Qualifications
- Bachelor's degree in engineering, life sciences, or an equivalent relevant discipline
- Advanced degree or formal program management certification
- Prior background guiding a CDx or IVD program through a major PMA milestone or final submission
- Exposure to genomic diagnostics, next-generation sequencing, or biomarker-selected patient groups
- Familiarity with coordinating clinical and analytical validation strategies alongside configuration changes between clinical trials and commercial assays
- Knowledge of pharmaceutical development lifelines and dependencies connecting therapeutic assets with companion diagnostics
Core Skills
Benefits
- Comprehensive medical, dental, vision, life, and disability insurance plans for eligible workers and dependents
- Free testing services for employees and immediate family members
- Fertility care benefits
- Pregnancy and baby bonding leave
- 401(k) retirement plan
- Commuter benefits
- Employee referral program
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, this role is listed as remote within the USA.
What is the salary range for this role?
The salary range is between $150,300 and $195,150 USD, though final compensation depends on factors such as candidate experience, skill set, certifications, and location.
What level of experience is required?
Candidates must have at least 10 years of progressive program or project management experience within regulated fields like biotechnology, molecular diagnostics, medical devices, or in vitro diagnostics.
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