Associate Director, Strategic Program Management
Core
Lead IVD and companion diagnostic (CDx) programs from development planning through PMA submission, integrating assay development, software, bioinformatics, validation, and regulatory activities.
Role type
Senior IC strategic program manager (medical devices/IVD)
Builds
Integrated execution plans for CDx/IVD programs leading to FDA PMA submission
Domain
Molecular diagnostics, in vitro diagnostics, medical devices, biotechnology
Required skills
Program management in regulated fields, IVD/CDx development lifecycle, FDA PMA submission preparation, cross-functional stakeholder leadership, risk management, executive communication, integrated planning across technical/clinical/regulatory functions
Preferred skills
PMA submission leadership, next generation sequencing, genomic diagnostics, biomarker-defined patient populations, analytical and clinical validation strategy, pharmaceutical development timelines, advanced degree, program management certification
Technologies
Next generation sequencing, bioinformatics, software for diagnostics
Responsibilities
Lead complex IVD/CDx programs through development, design transfer, validation, and PMA submission; Build and maintain integrated program plans covering deliverables, resources, dependencies, and regulatory milestones; Partner with functional leaders to define objectives and executable plans; Anticipate risks and drive timely decisions across functions; Establish program governance and accountability; Integrate assay development, software, bioinformatics, and validation activities; Coordinate plans for assay changes and bridging studies; Lead reviews at major development gates; Track submission-critical evidence and documentation; Present program strategy and risks to the Executive Leadership Team; Translate complex scientific and regulatory issues into data-backed options for decision-making.
Seniority
Senior, hands-on IC
