Associate Director, Strategic Program Management

Description

Associate Director, Strategic Program Management, CDx/IVD. The company develops in vitro diagnostic and companion diagnostic tests and is built around cell-free DNA testing in oncology, women's health and organ health.

This leader owns the integrated plan for IVD and companion diagnostic programs, from development planning through PMA submission. You will help set development strategy with functional experts and coordinate assay development, software and bioinformatics, analytical and clinical validation, lab operations, Quality and Regulatory Affairs.

The role is high-visibility and works through influence rather than direct authority. You will sort out competing priorities, link decisions across workstreams and bring clear recommendations to the Executive Leadership Team (ELT). The focus is internal CDx development and execution. Dedicated partnership leaders handle relationships with external pharmaceutical partners.

Responsibilities

• Lead complex IVD and CDx programs from development through design transfer, validation and PMA submission.
• Build and maintain one integrated plan that tracks deliverables, resources, dependencies, decision points and regulatory milestones.
• Work with functional leaders to set objectives, priorities, success criteria and workable plans.
• Spot risks, gaps and trade-offs early and push for timely cross-functional decisions.
• Set up program governance, ownership, escalation paths and accountability for commitments.
• Bring together assay development, design controls, software and bioinformatics, analytical and clinical validation, lab implementation and submission work.
• Work with Regulatory Affairs and Quality so program execution matches FDA interactions, applicable requirements and PMA evidence needs.
• Plan assay changes, comparability or bridging studies and the move to the final CDx configuration, where relevant.
• Lead reviews at major development gates covering deliverables, readiness criteria, open risks and decisions.
• Track submission-critical evidence and documentation, and close gaps that could affect PMA quality or timing.
• Present strategy, progress, risks, trade-offs and recommendations to the ELT and other senior governance forums.
• Turn complex scientific, operational and regulatory issues into concise, data-backed options.
• Align leaders with different priorities and hold teams to agreed actions and milestones.
• Raise material issues early, with an impact assessment and a recommended path forward.
• Give internal program status and decision support to colleagues who manage external pharmaceutical partner relationships.

Requirements

• Required: a bachelor's degree in life sciences, engineering or a related field, or equivalent relevant experience.
• Required: 10+ years of progressive program or project management in molecular diagnostics, in vitro diagnostics, medical devices, biotechnology or another related regulated field.
• Required: direct experience leading CDx or IVD programs that involved design controls, validation planning and FDA submission preparation.
• Required: experience building and running integrated plans across technical, clinical, regulatory, quality, software and operations teams.
• Required: a track record of leading senior cross-functional stakeholders, settling competing priorities and delivering results without direct reporting authority.
• Required: experience presenting complex programs, risks and recommendations to executive leadership.
• Required: a strong ability to link technical decisions, resource needs, regulatory evidence and timelines to overall program strategy.
• Preferred: experience taking 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 trial and final commercial assay configurations.
• Preferred: familiarity with pharmaceutical development timelines and how a therapeutic program depends on its companion diagnostic.
• Preferred: an advanced degree or a program management certification.
• The successful candidate goes beyond milestone tracking. You will understand the science and regulatory strategy well enough to ask good questions, notice when a decision in one area creates risk in another, and bring the right people together to fix it. You will build trust and open discussion, make ownership clear, and give executives an accurate picture of progress and the decisions needed.

Conditions

Remote, USA. Base pay range is $150,300 to $195,150 USD.

Actual pay depends on factors such as skill set, depth and years of experience, certifications and office location. Ranges may differ in other locations due to labor costs.

Equal opportunity employer that welcomes people of all backgrounds, experiences, abilities and perspectives.

Benefits

• Comprehensive medical, dental, vision, life and disability coverage for eligible employees and their dependents.
• Free testing for employees and immediate family, plus fertility care benefits.
• Pregnancy and baby bonding leave, a 401(k), commuter benefits and more.
• A generous employee referral program.