Manager/Associate Director, Project Management -Combination Products
The Manager/Associate Director, Project Management -Combination Products is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Primary Packaging, Accessories, Secondary Packaging, Instructions for Use and Labeling). The Associate Director ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.
Summary of Responsibilities and Accountabilities:
The Manager/Associate Director will be accountable to the CMC team, the CMC Product Development Director and delivery system Senior Leadership for delivering on the strategy, plans and budget defined for the project portfolio.
- Leadership of a portfolio of drug delivery system product development projects
- Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
- Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
- Representing the R&D organization to cross functional leadership through effective and timely communication
- Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
- Driving continuous improvement on Program/project management processes and tools
- Direct management of project managers with responsibility for device/device constituent development projects
Management of External Partners: The Manager/Associate Director, Project Management -Combination Products leads the team in managing the relationship and performance of key external device development partners. An effective and efficient development partner governance process should be defined and implemented including: key interface definition, meeting cadence, schedule performance monitoring, project scope/change control, issue escalation, and financial tracking. Program risks must be identified and mitigated with the partner throughout the program lifecycle. The Associate Director will ensure timely and efficient communication regarding partner performance will be provided to the broader AbbVie organization as required. The Associate Director will work with the AbbVie contracts team and the partner to define and track performance to the Statement of Work. The Associate Director will provide accurate and timely cost estimates for budgeting and forecasting.
Functional Management: The Manager/Associate Director, Project Management -Combination Products may directly manage a small group of Project Managers through efficient distribution of project responsibilities, support of opportunities for professional development, and actionable and timely feedback on performance. This includes a focus on continuous improvement of the group’s competency in project and program management and product development related processes.
Impact on AbbVie: The role of the Manager/Associate Director, Project Management -Combination Products has broad influence and impact on the development and launch of AbbVie’s assets when a device/combination product delivery system is required. These device systems are often technically complex, involve multiple sub-systems, interface directly with the patient, and must meet global requirements. Typically, external partner management is required. The Associate Director must represent the R&D function to cross functional leadership through effective communication and use of influence skills
*This position can be hired as a Manager, Project Management-Combination Products or Associate Director, Project Management- Combination Products