Device Development Lead, Associate Director
Core
Lead end-to-end device program execution from clinical development through commercialization, ensuring alignment of device strategy with drug development and business goals.
Role type
Senior Associate Director, Device Development Lead
Builds
Medical device programs for pharmaceutical/biotech products
Domain
Pharmaceutical/Medical Device Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cross-functional team leadership, global program management, budgeting and resource deployment, risk management, regulatory compliance (FDA/EU MDR), subcontractor/CMO management, strategic planning, stakeholder governance
Preferred skills
Life Cycle Management (LCM) experience, digital health integration, geographic expansion planning
Technologies
Microsoft Project, integrated development plans, risk management tools
Responsibilities
Lead cross-functional teams through clinical development and commercialization; manage device program budgets (OPEX/CAPEX/FTE); monitor program risk and provide mitigation solutions; align device strategy with drug Target Product Profile; represent device team at product governance bodies; oversee quality assurance and regulatory compliance; manage relationships with OEM suppliers and contract R&D/manufacturing organizations.
Seniority
Senior, hands-on IC with strategic oversight
