Senior Strategic Program Manager
Core
Lead cross-functional R&D programs to launch new clinical diagnostic products and enhance existing ones in a regulated environment.
Role type
Senior Strategic Program Manager (Program Management Office)
Builds
New clinical diagnostic products and enhanced existing products for patients worldwide
Domain
Biotech / Life Sciences / Clinical Diagnostics
Required skills
Program management, Design Control, New Product Introduction, Cross-functional collaboration, Risk management, Data-driven reporting, Project planning, Regulatory compliance, Budget management, Stakeholder influence
Preferred skills
FDA Design Controls knowledge, Laboratory informatics (LIMS), Software development lifecycle, Agile tools, Trade-off analysis
Technologies
SmartSheet, Jira, GitLab, LIMS
Responsibilities
Drive cross-functional programs from concept to commercialization, Partner across R&D/business/operations/engineering to define goals and plans, Lead all phases of product development, Develop and maintain program documentation, Track progress and communicate results to leadership, Champion Design Control excellence, Facilitate team meetings to drive decisions and mitigate risks, Guide trade-off and risk decisions, Coordinate joint development with external partners, Manage up to 4 dynamic programs simultaneously
Seniority
Senior, hands-on IC