Associate Director, Drug-Device Combination Development Lead (DDL)
Core
Lead drug-device combination product development activities, coordinating device sub-team execution and strategy across the product lifecycle.
Role type
Senior IC drug-device combination development lead
Builds
Drug-device combination products (e.g., prefilled systems, primary packaging)
Domain
Pharmaceutical R&D / Drug-device combination development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug-device combination product development, container closure/primary packaging, cross-functional matrix team leadership, external partner/supplier management, regulatory frameworks for combination products, risk-based decision making, integrated planning, technology scouting
Preferred skills
MS/PhD, experience in biotech/pharma
Technologies
Microsoft tools
Responsibilities
Develop and drive product-specific drug-device combination strategy across the lifecycle; Lead the device subteam for drug-device combination product development; Coordinate device qualification activities and drug-device compatibility strategy; Represent the device subteam on cross-functional program teams; Establish and maintain collaborative relationships with external partners (vendors, OEMs, testing labs, CMOs)
Seniority
Senior, hands-on IC
