Associate Director, Strategic Program Management
Core
Lead high-complexity In Vitro Diagnostics (IVD) development programs from initiation through commercialization, serving as the primary point of contact for pharma and biotech partners.
Role type
Senior IC Associate Director, Strategic Program Management
Builds
IVD development programs and PMA submissions for Natera's oncology, women's health, and organ health portfolio
Domain
Medical Devices / In Vitro Diagnostics (IVD) / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
IVD development lifecycle expertise, PMA submission leadership, integrated master project scheduling, risk register management, change control log ownership, cross-functional stakeholder alignment, budget forecasting, regulatory compliance (21 CFR Part 820, ISO 13485)
Preferred skills
Companion diagnostics (CDx) co-development, EU IVDR regulatory pathways, clinical or analytical laboratory background
Technologies
MS Project, Smartsheet
Responsibilities
Manage concurrent IVD programs ensuring on-time/on-budget delivery; maintain real-time command of milestones and dependencies; develop executive dashboards; lead cross-functional meetings to clear decisions; mentor junior PMs; drive PMA submission readiness; standardize PMO frameworks; proactively surface risks to leadership.
Seniority
Senior, hands-on IC with strategic oversight