Associate Director, Drug-Device Combination Development Lead (DDL)
Core
Lead drug-device combination product development activities and coordinate the device sub-team for assigned assets across the product lifecycle.
Role type
Senior IC Associate Director, Drug-Device Combination Development Lead
Builds
Drug-device combination products (e.g., prefilled systems and primary packaging)
Domain
Pharmaceutical industry, Drug-Device Combination Development
Required skills
Drug-device combination product strategy, Device sub-team leadership, Cross-functional stakeholder management, Risk-based decision making, Regulatory framework knowledge, External partner/supplier management
Preferred skills
MS/PhD in engineering or pharmaceutical sciences, Experience with container closure/primary packaging, Model-informed approaches
Technologies
Microsoft tools, Integrated plans, Risk registers
Responsibilities
Develop and drive product-specific drug-device combination strategy across the lifecycle, Lead the device sub-team for development and qualification, Represent the device sub-team on cross-functional program teams, Establish and maintain collaborative relationships with external partners
Seniority
Senior, hands-on IC