Associate Director, Strategic Program Management (CDx/IVD)

Location: US Remote; other listed location: US - SC.

Salary: $150,300–$195,150 USD.

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Lead complex IVD and companion diagnostic programs through development, design transfer, validation, and PMA submission.
• Build integrated plans covering deliverables, resources, dependencies, decision points, governance, and regulatory milestones.
• Coordinate assay development, design controls, software and bioinformatics, analytical and clinical validation, laboratory implementation, Quality, Regulatory Affairs, and submission activities.
• Anticipate risks, identify gaps and trade-offs, drive decisions, and establish accountability across cross-functional workstreams.
• Present strategy, progress, risks, trade-offs, and recommendations to the Executive Leadership Team and other senior governance forums.
• Track submission-critical evidence and documentation, resolve gaps, and support internal decision-making for external pharmaceutical partner relationships.

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.

Nice to have

• Experience leading a CDx or IVD program through PMA submission or a major PMA milestone.
• Experience with next-generation sequencing, genomic diagnostics, or biomarker-defined patient populations.
• Experience coordinating analytical and clinical validation strategies and managing changes between clinical-trial and final commercial assay configurations.
• Familiarity with pharmaceutical development timelines and dependencies between therapeutic programs and companion diagnostics.
• Advanced degree or program management certification.

Culture & Benefits

• Employee position with medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• Free testing for employees and immediate family members, fertility care benefits, pregnancy and baby bonding leave, 401(k), commuter benefits, and referral benefits.
• Work remotely in the United States.
• Inclusive workplace committed to equal opportunity and collaboration across diverse backgrounds and perspectives.