Head of Device Development (Vice President)

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Job Description

Objectives/Purpose:

• Leads the global Device Development organization and end-to-end delivery of device and combination product engineering from early feasibility through Design Controls, tech transfer, launch, and sustaining engineering.

• Owns the enterprise device/combination product strategy across modalities, ensuring fit-for-purpose platforms and capabilities aligned to pipeline needs.

• Partners with other PharmSci functions, Drug Product departments and key external stakeholders (GSQ, Quality, Regulatory CMC, Clinical, Commercial) to deliver compliant, scalable, patient-centered delivery solutions.

Accountabilities:

• Owns and executes the global device and combination product (drug-device) development strategy across the portfolio, aligned to TAU and pipeline needs, from early feasibility through lifecycle management.

• Leads end-to-end device engineering and Design Controls execution (user needs, design inputs/outputs, risk management, verification/validation, DHF/DMR/tech file readiness) for both internal and partner-developed systems.

• Accountable for robust, phase-appropriate device/combination product CMC strategies, including human factors/usability engineering, reliability engineering, and design-for-manufacture/assembly/serviceability.

• Ensures compliant global regulatory delivery of device/combination product content within IND/CTA/MAA/NDA/BLA submissions as applicable, including effective health authority engagement and right-first-time responses.

• Leads device industrialization and tech transfer to manufacturing and suppliers, including process validation strategy (as applicable), supplier qualification, and scalable manufacturing controls for commercial readiness.

• Establishes and governs a platform-device and primary container/closure strategy (where relevant) to improve speed, cost, and reuse across programs while maintaining patient safety, quality, and performance.

• Owns post-launch sustaining engineering strategy and execution (complaints, investigations, CAPA, change control, obsolescence, supplier changes, field actions/recalls support) in partnership with Quality/GSQ.

• Drives external innovation and partnerships (device suppliers, CDMOs/CMOs, design houses, digital/connected device partners), including build/buy/partner decisions and IP strategy support.

• Champions digital engineering capabilities (model-based design, simulation, tolerance analysis, reliability modeling, and data-driven failure analysis) to reduce iteration cycles and improve predictability.

• Builds, develops, and leads a high-performing global organization; sets clear operating mechanisms, talent strategy, and resource allocation across programs and geographies.

Core Elements Related to this Role:

Dimensions and Aspects:

Technical/Functional (Line) Expertise:

• Deep expertise in drug delivery device development and combination products, spanning early concept/feasibility through Design Controls, industrialization, launch, and sustaining engineering.

• Demonstrated experience with global device and combination product regulatory expectations and standards (e.g., FDA device/combination product requirements, EU MDR/IVDR where relevant, ISO 13485, ISO 14971, IEC 62366, relevant USP/ISO standards for delivery systems/containers).

• Strong technical depth in human factors engineering/usability, risk management, reliability engineering, materials selection, and design-for-manufacture/assembly.

• Proven experience leading supplier ecosystems and outsourced development/manufacture: supplier qualification, quality agreements, audits, change management, and performance governance.

• Track record of successful approvals and commercialization for device and/or combination products, including robust documentation (DHF/technical files) and cross-functional launch execution.

• Understanding of interface points to drug product development (e.g., container closure systems, extractables/leachables