Director, Program Management, Delivery Systems and Combination Products

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Overview

The Director of Program Management 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 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 Asset team. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.

Accountability

The 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.

Responsibilities:

• 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 Director 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 Director will ensure timely and efficient communication regarding partner performance will be provided to the broader AbbVie organization as required . The Director will work with the AbbVie contracts team and the partner to define and track performance to the Statement of Work. The Director will provide accurate and timely cost estimates for budgeting and forecasting.

Functional Management: The Director of Program Management directly manages a 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 Director of Program Management 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 Director must represent the R&D function to cross functional leadership through effective communication and use of influence skills

Qualifications

• 18+ (BS/BA), 16+ (MS/MA) or 10+ (PhD) years of experience in the combination product or medical device industry with proven experience in developing and launching combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
• Bachelor's Degree in Engineering or related technical field is required
• Masters in Engineering or Business Administration is preferred
• Certification: Project Management Professional (PMP) Certification preferred
• Leadership of technical professionals; proven effective leader to cross-functional teams with focus on commercialization, equipment selection, build and qualification of delivery systems
• On-body delivery systems, auto-injectors, pumps and pre-filled syringes and smart packaging design experience required.
• Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems.
• Requires an in-depth understanding of the pharmaceutical product development cycle.
• Design history file, project management and product development experience is essential.
• Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.
• Ensure timely execution of incoming reportable device combination product events to comply with global regulations.
• Must have working understanding and application of GMP principles, concepts, practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States, Europe, Asia, Latin America).
• Up to 25% travel may be required to effectively manage communication between multiple Abbvie sites and third-party suppliers

Significant Work Activities
N/A
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.