Associate Director, Concept Development and Delivery
Core
Lead concept development and delivery for drug-device combination (DDC) products, integrating technical attributes, patient needs, and business requirements to improve technical success probability.
Role type
Associate Director, Product Development (Drug-Device Combination)
Builds
Robust patient-centric devices and primary packaging solutions for novel pharmaceuticals across all modalities.
Domain
Biopharmaceuticals / Medical Devices / Drug-Device Combination (DDC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features
Required skills
CMC Strategy, Design Controls, Risk Management, Design History File, Supplier Management, Technology Transfer, Process Optimization, Project Leadership, Regulatory Frameworks (21 CFR QSR, ISO 13485, ISO 14971), Simulation and Modeling
Preferred skills
Parenteral delivery systems expertise, Multi-modality experience (biologics, small molecules, vaccines), Human factors engineering, Statistical analysis, Cross-functional leadership
Technologies
21 CFR QSR, ISO 13485, ISO 14971, Simulation tools, Statistical analysis software
Responsibilities
Collaborate with Discovery, Clinical, Commercial, and Manufacturing teams to develop on-target DDC products; Systematically engage stakeholders to define technical requirements, product concepts, and investment tradeoffs; Identify and mitigate technical risks through testing and modeling; Plan and execute engineering studies, device characterization, and validation; Author and review technical documentation for regulatory submissions; Support industrialization and technology transfer to manufacturing sites; Monitor industry trends and collaborate with academia and professional consortiums.
Seniority
Senior, hands-on IC with leadership responsibilities
