We are seeking an experienced Director to lead the Lake County Combination Product Development (CPD) team and serve as the site lead for AbbVie’s combination product development activities in R&D. This highly visible leadership role is responsible for driving the clinical development of combination products spanning prefilled syringes, autoinjectors, on-body injectors, and subcutaneous ambulatory infusion pumps. The Director will provide strategic and operational leadership across a technically diverse, cross-functional team, ensuring successful development of device and delivery systems.
This role will support the development of new device and platform technologies. The role is accountable for building the systems, processes, capabilities, and partnerships required to advance product development with technical rigor, customer focus, and timely execution. This role will work closely with peers in R&D and cross-functional colleagues in a global organization as well as maintaining strong working relationships with external development partners throughout the product development process.
Responsibilities:
- Provide strategic and operational leadership for all combination product development activities at the LC site, driving innovation and excellence in device and drug-device platform development.
- Direct oversight spans early feasibility assessment, design analysis and optimization, platform customization, reliability engineering, specifications development, verification testing, and issue resolution across the full program lifecycle.
- Oversee project teams responsible for the broader product development lifecycle—from concept through design, engineering, verification/validation, and transition to operations.
- Build and lead a high-performing, multidisciplinary site team comprising engineering, science, and technical staff, directly managing managers, project leads, and technical specialists.
- Lead engineers responsible for design fundamentals, margin analysis, reliability assessment, and continuous improvement opportunities across a diverse portfolio of delivery systems. The engineering team includes mechanical, electrical, software, and materials science subject matter experts.
- Oversee the lab and design verification teams to support design, development, and testing of combination products using state-of-the-art equipment.
- Collaborate with global and cross-functional stakeholders (R&D, Regulatory, Quality, Operations, Supply) to ensure development deliverables meet timelines and regulatory requirements. While program managers own timeline management, provide technical leadership and granular program insights to identify acceleration opportunities, develop contingency strategies, and enable informed decision-making across the development lifecycle.
- Develop and manage resource allocation, and ensure availability of state-of-the-art tools and equipment, laboratory capabilities, and talent.
- Develop and implement staffing plans for global pipeline development programs using both internal staff and external contract resources.
- Foster a culture of technical rigor, quality, and continuous improvement; anticipate and proactively work with global teams to resolve technical and operational issues.
- Champion talent development, mentorship, and succession planning within the LC site.
- Proactively manage global third-party development partners across a broad range of drug delivery system technologies and device types.
- Represent the LC site in cross-site collaboration, global forums, and leadership meetings; contribute to broader organizational strategy for combination products.