Associate Director, Strategic Program Management

🕒 November 2

🇺🇸 United States – Remote

💵 $150.3k - $195.2k / year

⏰ Full Time

🟠 Senior

📋 Program Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 10 days.
• Jobs at this company usually fill in 21 days.

Apply Now

Find Similar Remote Jobs

Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume