Director, Site Lead Combination Product Development, R&D

Responsibilities

• Oversee project teams responsible for the broader product development lifecycle-from concept through design, engineering, verification/validation, and transition to operations.
• Oversee the lab and design verification teams to support design, development, and testing of combination products using state-of-the-art equipment.
• 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.
• Advanced degree (MS/PhD) in pharmaceutical or engineering discipline.
• Minimum 15 years of relevant industry experience in medical devices and/or pharmaceutical industry, including at least 8 years of leading product development teams. Prior experience with subcutaneous injection devices and electromechanical devices is highly desirable.
• Demonstrated expertise in combination product/device design, development, verification/validation, and technology transfer. Product development leading to commercial launch is a plus.
• Strong working knowledge of applicable global regulatory requirements and industry standards (e.g., 21 CFR 820.30, ISO 13485, MDR, etc.).
• Solid R&D experience employing modern, lean product development methodologies across large multi-disciplinary teams.
• Experience in cross-functional process improvement - identifying and implementing ways to remove barriers, improve efficiency, and allow teams to move fast.
• Ability to help teams navigate risk and ambiguity - identifying additional information needed and enabling high-quality decisions to support development.
• Outstanding ability to lead teams, communicate across functions, and influence senior/global stakeholders.
• Demonstrated knowledge of business and leadership principles involved in strategic planning, tactical execution, resource allocation, and team coordination.
• Proven track record

Additional Information

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.

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